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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.

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Official Title

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Efficacy and Safety of Exenatide in Japanese Patients with Type 2 Diabetes Who are Treated with Oral Antidiabetic(s)

subcutaneous injection, 5mcg, twice a day

subcutaneous injection, 10mcg, twice a day

subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Research Site

Efficacy and Safety of LY2148568 in Japanese Patients with Type 2 Diabetes Who are Treated with Oral Antidiabetic(s) but not well Controlled

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

AgeCategoricalNLM

AgeContinuous

GenderNIH

Full analysis set; Last observation carried forward.

Change in glycosylated hemoglobin (HbA1c) from baseline to week 24

Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)

Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.

Percentage of patients achieving HbA1c < 7.0%

Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)

Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.

Percentage of patients achieving HbA1c < 6.5%

Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

Full analysis set; Last observation carried forward

Change in fasting blood glucose

Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

Change in body weight

Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

Change in total cholesterol

Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

Change in low density lipoprotein cholesterol (LDL-C)

Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

Change in high density lipoprotein cholesterol (HDL-C)

Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

Change in triglycerides

Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

Full Analysis Set; Last Observation Carried Forward

Change in waist size

Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0).  Waist-to-hip ratio is waist circumference divided by hip circumference.

Change in waist-to-hip ratio

30 minutes prior to breakfast SMBG at week 0

30 minutes prior to breakfast SMBG at week 24

2hr post-breakfast SMBG at week 0

2hr post-breakfast SMBG at week 24

30 minutes prior to lunch SMBG at week 0

30 minutes prior to lunch SMBG at week 24

2hr post-lunch SMBG at week 0

2hr post-lunch SMBG at week 24

30 minutes prior to dinner SMBG at week 0

30 minutes prior to dinner SMBG at week 24

2hr post-dinner SMBG at week 0

2hr post-dinner SMBG at week 24

bedtime SMBG at week 0

bedtime SMBG at week 24

Self-monitored blood glucose at 7 different time points during the day (glucose
measurements before and 2 hours after the start of the morning, midday,
and evening meals, and at bedtime).

7 point self-monitored blood glucose (SMBG) profiles at baseline and week 24

Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0).  HOMA-B is a measurement of beta cell function.

Change in homeostasis model assessment - beta cell function (HOMA-B)

Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0).  HOMA-R is a measurement of insulin resistance.

Change in homeostasis model assessment - insulin resistance (HOMA-R)

Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

Change in serum insulin

Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

Change in C-peptide

Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

Arms	Assigned Interventions
Experimental: 1	Drug: exenatide subcutaneous injection, 5mcg, twice a day Other Name: LY2148568 Other Name: Byetta
Experimental: 2	Drug: exenatide subcutaneous injection, 10mcg, twice a day Other Name: LY2148568 Other Name: Byetta
Placebo Comparator: 3	Drug: placebo subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Efficacy and Safety of Exenatide in Japanese Patients with Type 2 Diabetes Who are Treated with Oral Antidiabetic(s)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Lilly Clinical Trial Registry

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator