An Evaluation of Exenatide and Rosiglitazone in Subjects with Type 2 Diabetes Mellitus

Study identifier:H8O-US-GWAY

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects with Type 2 Diabetes Mellitus Treated with Metformin

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Healthy volunteers

Study drug

exenatide, rosiglitazone

Sex

All

Actual Enrollment

137

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Oct 2005

Primary Completion Date: 01 Jul 2008

Study Completion Date: 01 Jul 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Location

Research Site

Renton, WA, United States

Location

Research Site

League City, TX, United States

Location

Research Site

Cincinatti, OH, United States

Location

Research Site

San Antonio, TX, United States

Location

Research Site

San Francisco, CA, United States

Location

Research Site

Boston, MA, United States

Location

Research Site

Phoenix, AZ, United States

Location

Research Site

Bronx, NY, United States

Arms	Assigned Interventions
Experimental: Exenatide Arm	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: Byetta
Experimental: Exenatide plus Rosiglitazone Arm	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: Byetta Drug: rosiglitazone oral tablet, 2mg or 4mg, twice a day Other Name: Avandia
Experimental: Rosiglitazone Arm	Drug: rosiglitazone oral tablet, 2mg or 4mg, twice a day Other Name: Avandia

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment occurred between 18 October 2005 and 14 March 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Participant Flow: Overall Study

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
STARTED	45	47	45
COMPLETED	33	34	34
NOT COMPLETED	12	13	11
Adverse Event	2	5	1
Lost to Follow-up	0	2	3
Physician Decision	1	1	0
Protocol Violation	4	3	3
Patient Decision	5	1	4
Sponsor Decision	0	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Baseline Measures

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone	Total
Number of Participants [units: Participants]	45	47	45	137.0
Age Categorical [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	36	37	36	109
>=65 years	9	10	9	28
Age Continuous [units: years] Mean ± Standard Deviation	56.99 ± 9.71	54.63 ± 9.91	55.54 ± 10.71	55.70 ± 10.09
Gender, Male/Female [units: participants]
Female	22	25	20	67
Male	23	22	25	70

Outcome Measures

1. Primary Outcome Measure: Change in ASIiAUC during a hyperglycemic clamp test. [ Time Frame: 20 weeks ]

Measure Type	Primary
Measure Name	Change in ASIiAUC during a hyperglycemic clamp test.
Measure Description	Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	17	18	15
Change in ASIiAUC during a hyperglycemic clamp test. [units: uIU-min/ml] Least Squares Mean (Standard Error)
Baseline ASIiAUC	643.40 (106.71)	686.41 (103.70)	786.12 (113.60)
Change in ASIiAUC at week 20	747.26 (187.40)	194.68 (181.59)	-99.85 (200.04)

Statistical Analysis 1 for Change in ASIiAUC during a hyperglycemic clamp test.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.282

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary Outcome Measure: Change in AUC for glucose during a meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in AUC for glucose during a meal challenge test (MCT).
Measure Description	Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	35	34
Change in AUC for glucose during a meal challenge test (MCT). [units: mmol-min/L] Least Squares Mean (Standard Error)
Baseline glucose AUC during MCT	1782.86 (60.47)	1799.68 (59.60)	1741.87 (60.47)
Change in glucose AUC during MCT at week 20	-560.12 (50.95)	-635.24 (50.25)	-425.59 (51.02)

Statistical Analysis 1 for Change in AUC for glucose during a meal challenge test (MCT).

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.004

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Secondary Outcome Measure: Change in insulin sensitivity index as measured by M-value. [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in insulin sensitivity index as measured by M-value.
Measure Description	Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	16	16	15
Change in insulin sensitivity index as measured by M-value. [units: mg/kg-min] Least Squares Mean (Standard Error)
M-Value at baseline	3.89 (0.495)	2.49 (0.495)	4.02 (0.511)
Change in M-Value from baseline at week 20	0.477 (0.425)	2.07 (0.440)	1.42 (0.442)

Statistical Analysis 1 for Change in insulin sensitivity index as measured by M-value.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.308

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

4. Secondary Outcome Measure: Change in insulin AUC in the first stage from baseline to endpoint. [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in insulin AUC in the first stage from baseline to endpoint.
Measure Description	Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who participated in clamp tests and have both baseline and endpoint

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	17	17	15
Change in insulin AUC in the first stage from baseline to endpoint. [units: uIU-min/ml] Least Squares Mean (Standard Error)
Baseline insulin AUC	200.50 (50.40)	136.84 (50.40)	157.49 (53.66)
Change from baseline insulin AUC at week 20	134.88 (31.71)	32.12 (31.65)	-50.81 (33.59)

Statistical Analysis 1 for Change in insulin AUC in the first stage from baseline to endpoint.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.079

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

5. Secondary Outcome Measure: Change in insulin iAUC from baseline to endpoint. [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in insulin iAUC from baseline to endpoint.
Measure Description	Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	17	17	15
Change in insulin iAUC from baseline to endpoint. [units: uIU-min/ml] Least Squares Mean (Standard Error)
Baseline insulin iAUC	5.98 (14.29)	-9.92 (14.29)	23.09 (15.21)
Change from baseline insulin iAUC at week 20	99.08 (24.23)	53.71 (24.54)	11.51 (26.15)

Statistical Analysis 1 for Change in insulin iAUC from baseline to endpoint.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.252

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

6. Secondary Outcome Measure: Ratio (value at endpoint divided by value at baseline) of AUC for insulin during a meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Ratio (value at endpoint divided by value at baseline) of AUC for insulin during a meal challenge test (MCT).
Measure Description	Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	35	33
Ratio (value at endpoint divided by value at baseline) of AUC for insulin during a meal challenge test (MCT). [units: uIU-min/ml] Geometric Mean (Standard Error)
Baseline AUC for insulin during MCT	5171.40 (522.82)	4324.13 (430.87)	5816.83 (596.91)
Ratio(endpoint/baseline) of insulin AUC during MCT	0.806 (0.063)	0.664 (0.052)	0.722 (0.058)

Statistical Analysis 1 for Ratio (value at endpoint divided by value at baseline) of AUC for insulin during a meal challenge test (MCT).

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.465

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

7. Secondary Outcome Measure: Change in AUC for C-peptide during a meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in AUC for C-peptide during a meal challenge test (MCT).
Measure Description	Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	34	32
Change in AUC for C-peptide during a meal challenge test (MCT). [units: nmol-min/L] Geometric Mean (Standard Error)
Baseline C-peptide during a MCT	319.77 (18.13)	310.51 (17.61)	325.65 (19.04)
Ratio(endpoint/baseline) of C-peptide during a MCT	0.908 (0.040)	0.804 (0.036)	0.854 (0.039)

Statistical Analysis 1 for Change in AUC for C-peptide during a meal challenge test (MCT).

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.348

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

8. Secondary Outcome Measure: Change in incremental for postprandial glucose during a meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in incremental for postprandial glucose during a meal challenge test (MCT).
Measure Description	Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	34	33
Change in incremental for postprandial glucose during a meal challenge test (MCT). [units: mmol/L] Least Squares Mean (Standard Error)
Baseline glucose at 15 min	0.950 (0.138)	1.12 (0.138)	0.828 (0.142)
Change fr baseline glucose at 15 min at wk 20	-0.651 (0.151)	-0.286 (0.152)	0.150 (0.157)
Baseline glucose at 30 min	2.39 (0.218)	2.54 (0.221)	2.23 (0.221)
Change fr baseline glucose at 30 min at wk 20	-1.46 (0.248)	-1.06 (0.252)	-0.066 (0.252)
Baseline glucose at 60 minutes	3.59 (0.273)	3.88 (0.273)	3.48 (0.273)
Change fr baseline glucose at 60 min at wk 20	-2.56 (0.329)	-2.46 (0.330)	-0.720 (0.329)
Baseline glucose at 90 minutes	3.24 (0.231)	3.36 (0.228)	3.48 (0.239)
Change fr baseline glucose at 90 min at wk 20	-2.87 (0.312)	-2.91 (0.307)	-0.952 (0.322)
Baseline glucose at 120 minutes	2.49 (0.235)	2.24 (0.238)	2.31 (0.235)
Change fr baseline glucose at 120 min at wk 20	-2.24 (0.271)	-2.52 (0.275)	-0.912 (0.271)
Baseline glucose at 150 minutes	1.62 (0.230)	1.14 (0.230)	1.25 (0.230)
Change fr baseline glucose at 150 min at wk 20	-1.42 (0.288)	-1.95 (0.287)	-0.830 (0.286)
Baseline glucose at 180 minutes	0.461 (0.235)	0.036 (0.235)	0.279 (0.235)
Change fr baseline glucose at 180 min at wk 20	-0.583 (0.231)	-0.995 (0.232)	-0.481 (0.230)

No statistical analysis provided for Change in incremental for postprandial glucose during a meal challenge test (MCT).

9. Secondary Outcome Measure: Change in incremental for postprandial insulin during meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in incremental for postprandial insulin during meal challenge test (MCT).
Measure Description	Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	35	32
Change in incremental for postprandial insulin during meal challenge test (MCT). [units: mmol/L] Least Squares Mean (Standard Error)
Baseline insulin at 15 min	9.97 (1.71)	8.09 (1.71)	7.53 (1.79)
Change fr baseline insulin at 15 min at wk 20	-1.71 (1.45)	-1.84 (1.45)	-0.455 (1.52)
Baseline insulin at 30 min	19.81 (2.28)	14.79 (2.25)	18.83 (2.35)
Change fr baseline insulin at 30 min at wk 20	-3.00 (1.90)	-2.63 (1.89)	-1.04 (1.96)
Baseline insulin at 60 min	27.92 (4.68)	27.67 (4.61)	32.09 (4.75)
Change fr baseline insulin at 60 min at wk 20	-11.04 (2.63)	-7.47 (2.59)	-7.42 (2.67)
Baseline insulin at 90 min	26.06 (4.10)	21.85 (4.10)	32.25 (4.36)
Change fr baseline insulin at 90 min at wk 20	-9.42 (2.72)	-9.27 (2.74)	-6.19 (2.92)
Baseline insulin at 120 min	19.56 (2.99)	17.52 (2.99)	25.47 (3.04)
Change fr baseline insulin at 120 min at wk 20	-11.26 (1.99)	-8.69 (2.00)	-6.43 (2.04)
Baseline insulin at 150 min	15.67 (2.47)	12.74 (2.43)	18.11 (2.51)
Change fr baseline insulin at 150 min at wk 20	-7.48 (1.74)	-8.13 (1.73)	-5.57 (1.78)
Baseline insulin at 180 min	10.58 (1.73)	8.18 (1.73)	10.74 (1.79)
Change fr baseline insulin at 180 min at wk 20	0.031 (1.30)	-5.26 (1.30)	-4.04 (1.34)

No statistical analysis provided for Change in incremental for postprandial insulin during meal challenge test (MCT).

10. Secondary Outcome Measure: Change in incremental for postprandial C-peptide during meal challenge test (MCT). [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in incremental for postprandial C-peptide during meal challenge test (MCT).
Measure Description	Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in full analysis set who have baseline and endpoint measurement.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	34	32
Change in incremental for postprandial C-peptide during meal challenge test (MCT). [units: mmol/L] Least Squares Mean (Standard Error)
Baseline C-peptide at 15 min	0.238 (0.049)	0.259 (0.049)	0.206 (0.051)
Change fr baseline C-peptide at 15 min at week 20	-0.006 (0.045)	0.016 (0.046)	0.087 (0.047)
Baseline C-peptide at 30 min	0.521 (0.059)	0.517 (0.059)	0.560 (0.061)
Change fr baseline C-peptide at 30 min at week 20	-0.071 (0.056)	-0.036 (0.056)	0.099 (0.058)
Baseline C-peptide at 60 min	0.818 (0.110)	0.871 (0.110)	0.881 (0.114)
Change fr baseline C-peptide at 60 min at week 20	-0.148 (0.090)	-0.025 (0.090)	0.054 (0.093)
Baseline C-peptide at 90 min	0.895 (0.100)	0.953 (0.101)	1.03 (0.106)
Change fr baseline C-peptide at 90 min at week 20	-0.185 (0.099)	-0.117 (0.101)	-0.052 (0.106)
Baseline C-peptide at 120 min	0.817 (0.112)	0.828 (0.114)	0.972 (0.114)
Change fr baseline C-peptide at 120 min at week 20	-0.259 (0.100)	-0.134 (0.102)	-0.016 (0.102)
Baseline C-peptide at 150 min	0.843 (0.091)	0.651 (0.091)	0.813 (0.092)
Change fr baseline C-peptide at 150 min at week 20	-0.251 (0.095)	-0.254 (0.095)	-0.093 (0.096)
Baseline C-peptide at 180 min	0.610 (0.084)	0.482 (0.085)	0.619 (0.087)
Change fr baseline C-peptide at 180 min at week 20	-0.075 (0.062)	-0.238 (0.063)	-0.092 (0.064)

No statistical analysis provided for Change in incremental for postprandial C-peptide during meal challenge test (MCT).

11. Secondary Outcome Measure: Change in HbA1c [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in HbA1c
Measure Description	Change in HbA1c from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	35	36	34
Change in HbA1c [units: Percentage] Least Squares Mean (Standard Error)
Baseline HbA1c	7.79 (0.116)	7.84 (0.115)	7.92 (0.116)
Change from baseline HbA1c at week 20	-0.908 (0.118)	-1.31 (0.116)	-0.968 (0.118)

Statistical Analysis 1 for Change in HbA1c

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Mixed Model Repeated Measures (MMRM)]
P-Value^[4]	0.039

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

12. Secondary Outcome Measure: Change in fasting serum glucose concentration. [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting serum glucose concentration.
Measure Description	Change in fasting serum glucose concentration from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	35	34
Change in fasting serum glucose concentration. [units: mmol/L] Least Squares Mean (Standard Error)
Baseline fasting serum glucose	8.42 (0.278)	8.43 (0.271)	8.48 (0.274)
Change fr baseline fasting serum glucose at wk 20	-1.46 (0.250)	-1.60 (0.244)	-1.80 (0.250)

Statistical Analysis 1 for Change in fasting serum glucose concentration.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.555

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

13. Secondary Outcome Measure: Change in fasting C-peptide [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting C-peptide
Measure Description	Change in fasting C-peptide from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	0	0	0
Change in fasting C-peptide [units: nmol/L] Geometric Mean (Standard Error)

No statistical analysis provided for Change in fasting C-peptide

14. Secondary Outcome Measure: Change in fasting insulin [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting insulin
Measure Description	Change in fasting insulin from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	35	35	31
Change in fasting insulin [units: uIU/ml] Geometric Mean (Standard Error)
Baseline fasting insulin	12.84 (1.55)	10.96 (1.33)	12.77 (1.54)
Ratio (wk20/baseline)of fasting insulin	0.980 (0.096)	0.599 (0.059)	0.755 (0.078)

Statistical Analysis 1 for Change in fasting insulin

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.106

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

15. Secondary Outcome Measure: Change in fasting proinsulin [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting proinsulin
Measure Description	Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	34	33
Change in fasting proinsulin [units: pmol/L] Geometric Mean (Standard Error)
Baseline fasting proinsulin	4.32 (0.523)	3.80 (0.455)	3.56 (0.423)
Ratio(wk20/baseline)of fasting proinsulin	0.663 (0.073)	0.538 (0.058)	0.623 (0.068)

Statistical Analysis 1 for Change in fasting proinsulin

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.341

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

16. Secondary Outcome Measure: Change in body weight [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in body weight
Measure Description	Change in body weight from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who aave both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	44	45	44
Change in body weight [units: kg] Least Squares Mean (Standard Error)
Baseline body weight	93.05 (2.39)	93.76 (2.36)	91.78 (2.39)
Change in body weight at week 20	-2.82 (0.547)	-1.21 (0.538)	1.48 (0.547)

Statistical Analysis 1 for Change in body weight

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

17. Secondary Outcome Measure: Change in fasting total cholesterol. [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting total cholesterol.
Measure Description	Change in fasting total cholestrol from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	36	34
Change in fasting total cholesterol. [units: mmol/L] Least Squares Mean (Standard Error)
Baseline total cholesterol	4.42 (0.150)	4.41 (0.145)	4.62 (0.149)
Change fr baseline total cholesterol at week 20	-0.128 (0.118)	0.258 (0.114)	0.438 (0.118)

Statistical Analysis 1 for Change in fasting total cholesterol.

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.276

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

18. Secondary Outcome Measure: Change in fasting HDL cholesterol [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting HDL cholesterol
Measure Description	Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	36	34
Change in fasting HDL cholesterol [units: mmol/L] Least Squares Mean (Standard Error)
Baseline HDL	1.13 (0.048)	1.17 (0.047)	1.17 (0.048)
Change from baseline HDL at week 20	0.022 (0.030)	0.046 (0.029)	0.055 (0.030)

Statistical Analysis 1 for Change in fasting HDL cholesterol

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.840

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

19. Secondary Outcome Measure: Change in fasting LDL cholesterol [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting LDL cholesterol
Measure Description	Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	35	34
Change in fasting LDL cholesterol [units: mmol/L] Least Squares Mean (Standard Error)
Baseline LDL	2.59 (0.131)	2.57 (0.128)	2.71 (0.129)
Change from baseline LDL at week 20	-0.049 (0.102)	0.096 (0.100)	0.334 (0.101)

Statistical Analysis 1 for Change in fasting LDL cholesterol

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.096

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

20. Secondary Outcome Measure: Change in fasting triglycerides [ Time Frame: Week 20 ]

Measure Type	Secondary
Measure Name	Change in fasting triglycerides
Measure Description	Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.
Time Frame	Week 20
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who have both baseline and at least one post baseline value in full analysis set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	34	36	34
Change in fasting triglycerides [units: mmol/L] Geometric Mean (Standard Error)
Baseline triglyceride	1.56 (0.124)	1.67 (0.128)	1.76 (0.138)
Ratio (endpoint/baseline) for triglycerides	0.861 (0.060)	0.977 (0.066)	0.992 (0.069)

Statistical Analysis 1 for Change in fasting triglycerides

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.875

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

21. Secondary Outcome Measure: Change in percent body fat during a meal challenge test (MCT) [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in percent body fat during a meal challenge test (MCT)
Measure Description	Change in percent body fat from baseline to week 20, as assessed during an MCT
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	34	32
Change in percent body fat during a meal challenge test (MCT) [units: percentage] Least Squares Mean (Standard Error)
Baseline percent body fat	33.42 (1.16)	34.07 (1.15)	32.50 (1.18)
Change in percent body fat at week 20	-1.40 (1.06)	-0.347 (1.04)	-1.18 (1.08)

Statistical Analysis 1 for Change in percent body fat during a meal challenge test (MCT)

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.581

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

22. Secondary Outcome Measure: Change in body fat mass during a meal challenge test (MCT) [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in body fat mass during a meal challenge test (MCT)
Measure Description	Change in body fat mass form baseline to week 20, as assessed during an MCT
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	34	32
Change in body fat mass during a meal challenge test (MCT) [units: kg] Least Squares Mean (Standard Error)
Baseline body fat mass	32.05 (1.64)	32.55 (1.62)	30.54 (1.67)
Change in body fat mass at week 20	-2.76 (1.37)	-1.06 (1.35)	-1.99 (1.40)

Statistical Analysis 1 for Change in body fat mass during a meal challenge test (MCT)

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.631

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

23. Secondary Outcome Measure: Change in lean body mass during a meal challenge test (MCT) [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in lean body mass during a meal challenge test (MCT)
Measure Description	Change in lean body mass from baseline to week 20, as assessed during an MCT
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	34	32
Change in lean body mass during a meal challenge test (MCT) [units: kg] Least Squares Mean (Standard Error)
Baseline lean body mass	64.62 (2.11)	60.94 (2.08)	61.09 (2.14)
Change in lean body mass at week 20	-2.99 (1.39)	0.532 (1.37)	1.23 (1.41)

Statistical Analysis 1 for Change in lean body mass during a meal challenge test (MCT)

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.724

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

24. Secondary Outcome Measure: Change in waist circumference [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in waist circumference
Measure Description	Change in waist circumference from baseline to week 20
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	35	33
Change in waist circumference [units: cm] Least Squares Mean (Standard Error)
Baseline waist circumference	105.98 (1.68)	106.85 (1.67)	105.34 (1.67)
Change in waist circumference at Week 20	-2.95 (0.975)	-2.38 (0.955)	-0.225 (0.969)

Statistical Analysis 1 for Change in waist circumference

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.117

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

25. Secondary Outcome Measure: Change in hip circumference [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in hip circumference
Measure Description	Change in hip circumference form baseline to week 20
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	35	33
Change in hip circumference [units: cm] Least Squares Mean (Standard Error)
Baseline hip circumference	113.29 (1.71)	112.12 (1.69)	111.90 (1.69)
Change in hip circumference at week 20	-1.28 (0.848)	0.147 (0.827)	1.51 (0.838)

Statistical Analysis 1 for Change in hip circumference

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.251

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

26. Secondary Outcome Measure: Change in waist-to-hip ratio [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Change in waist-to-hip ratio
Measure Description	Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	33	35	33
Change in waist-to-hip ratio [units: ratio (cm/cm)] Least Squares Mean (Standard Error)
Baseline waist-to-hip ratio	0.939 (0.012)	0.957 (0.012)	0.943 (0.012)
Change in waist-to-hip ratio at week 20	-0.016 (0.011)	-0.022 (0.010)	-0.016 (0.011)

Statistical Analysis 1 for Change in waist-to-hip ratio

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [MMRM]
P-Value^[4]	0.710

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

27. Secondary Outcome Measure: Incidence of hypoglycemia events [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Incidence of hypoglycemia events
Measure Description	Number of subjects experiencing hypoglycemia at any point during the study
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	45	47	45
Incidence of hypoglycemia events [units: participants]	8	9	6

Statistical Analysis 1 for Incidence of hypoglycemia events

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Fisher Exact
P-Value^[4]	0.575

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

28. Secondary Outcome Measure: Hypoglycemia rate per 30 days per patient [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Hypoglycemia rate per 30 days per patient
Measure Description	Average number of episodes of hypoglycemia per 30 days per patient
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	45	47	45
Hypoglycemia rate per 30 days per patient [units: hypoglycemia events / 30 days / patient] Mean (Standard Deviation)	0.391 (0.298)	0.594 (0.436)	0.853 (1.05)

Statistical Analysis 1 for Hypoglycemia rate per 30 days per patient

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANOVA
P-Value^[4]	0.436

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

29. Secondary Outcome Measure: Pedal edema score [ Time Frame: 20 weeks ]

Measure Type	Secondary
Measure Name	Pedal edema score
Measure Description	Pedal edema scores experienced by each patient throughout the study ("1+" indicates a patient experienced a pedal edema score of 1 , 2, or 3; "2+" indicates a patient experienced a pedal edema score of 2 or 3, etc.) Scale: 1+ Slight pitting, no visible distortion, disappears rapidly 2+ A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 – 15 seconds 3+ The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen 4+ The pit is very deep, lasts as long as 2 – 5 minutes, and the dependent extremity is grossly distorted
Time Frame	20 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values

	Exenatide	Exenatide plus Rosiglitazone	Rosiglitazone
Number of Participants Analyzed [units:participants]	44	45	44
Pedal edema score [units: participants]
No edema	37	34	30
Edema score: 1+	7	11	14
Edema score: 2+	1	3	6
Edema score: 3+	0	0	1

Statistical Analysis 1 for Pedal edema score

Groups^[1]	Exenatide plus Rosiglitazone, Rosiglitazone
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Generalized Linear Model]
P-Value^[4]	0.168

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Serious Adverse Events

Exenatide

Exenatide plus Rosiglitazone

Rosiglitazone

Total, serious adverse events

# participants affected / at risk

3/---

4/---

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer¹,^†

# participants affected / at risk

0/---

1/---

0/---

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/---

1/---

Musculoskeletal and connective tissue disorders

Chest pain¹,^†

# participants affected / at risk

1/---

0/---

Gastrointestinal disorders

Colitis ischaemic¹,^†

# participants affected / at risk

0/---

1/---

0/---

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

0/---

1/---

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/---

0/---

Gastrointestinal disorders

Gastrointestinal haemorrhage¹,^†

# participants affected / at risk

0/---

1/---

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/---

0/---

Gastrointestinal disorders

Haemorrhoidal haemorrhage¹,^†

# participants affected / at risk

1/---

0/---

Infections and infestations

Helicobacter gastritis¹,^†

# participants affected / at risk

1/---

0/---

Psychiatric disorders

Major depression¹,^†

# participants affected / at risk

0/---

1/---

0/---

Infections and infestations

Osteomyelitis¹,^†

# participants affected / at risk

0/---

1/---

Infections and infestations

Otitis externa¹,^†

# participants affected / at risk

0/---

1/---

0/---

Renal and urinary disorders

Renal failure acute¹,^†

# participants affected / at risk

0/---

1/---

Infections and infestations

Staphylococcal infection¹,^†

# participants affected / at risk

1/---

0/---

Psychiatric disorders

Suicidal ideation¹,^†

# participants affected / at risk

0/---

1/---

0/---

Gastrointestinal disorders

Upper gastrointestinal haemorrhage¹,^†

# participants affected / at risk

0/---

1/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide plus Rosiglitazone	Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Other Adverse Events

Exenatide

Exenatide plus Rosiglitazone

Rosiglitazone

Total, other (not including serious) adverse events

# participants affected / at risk

35/---

41/---

33/---

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

21/---

22/---

2/---

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

10/---

9/---

0/---

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

6/---

7/---

3/---

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

2/---

5/---

9/---

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

3/---

10/---

2/---

Nervous system disorders

Headache¹,^†

# participants affected / at risk

5/---

4/---

3/---

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

3/---

5/---

2/---

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

5/---

1/---

2/---

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

3/---

1/---

4/---

General disorders and administration site conditions

Injection site bruising¹,^†

# participants affected / at risk

3/---

4/---

0/---

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

2/---

3/---

1/---

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/---

3/---

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

2/---

3/---

0/---

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

2/---

3/---

0/---

General disorders and administration site conditions

Hunger¹,^†

# participants affected / at risk

3/---

1/---

0/---

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

3/---

1/---

0/---

Respiratory, thoracic and mediastinal disorders

Pharyngolaryngeal pain¹,^†

# participants affected / at risk

1/---

0/---

3/---

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

0/---

3/---

General disorders and administration site conditions

Oedema¹,^†

# participants affected / at risk

0/---

3/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Peter Ohman, Medical Science Director
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

James Malone

Eli Lilly and Co.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site