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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

Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

CHOICE: CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy

subcutaneous injection, 5mcg or 10mcg, twice a day

Research Site

Research

CHOICE: CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy  - A European Observational Study of Patients with Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated with Treatment Changes and Outcomes over 24 Months

The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin: •Addition of a new medication for the treatment of type 2 diabetes •A change in the number of times insulin is administered per day •Discontinuation of any insulin initiated at baseline •Substitution of a human insulin for an analogue insulin or vice-versa. •Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change. Exenatide: •Addition of a new medication for the treatment of type 2 diabetes •Discontinuation of exenatide.

Age Continuous

Gender, Male/Female

Region of Enrollment

Glycosylated hemoglobin (HbA1c)

Study Specific Characteristic

Body Weight

Body Mass Index (BMI)

Duration of Diabetes

Number of patients on oral antidiabetic (OAD) medication at baseline. No differentiation possible if patients who did not report OADs actually took no OADs or just did not report them.

Concomitant Oral Anti-Diabetic Medication

Analysis population description: all patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline.

1- Serious adverse events (SAEs) and adverse events (AEs) were not collected as part of this observational study
2- Factors associated with treatment choice : this analysis was done on baseline lock( april 2009) where all others are from final lock.

Estimate at 24 months

Estimate at 12 months

The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.

Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.

Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:

Insulin:
•Addition of a new medication for the treatment of type 2 diabetes
•A change in the number of times insulin is administered per day
•Discontinuation of any insulin initiated at baseline
•Substitution of a human insulin for an analogue insulin or vice-versa.
•Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.

Exenatide:
•Addition of a new medication for the treatment of type 2 diabetes
•Discontinuation of exenatide.

All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.

Estimates of probability to remain on initial injectable treatment at 12 and 24 months.

Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.

Higher Body Mass Index (BMI) Associated with Treatment Choice at Baseline

Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.

Most recent HbA1c at baseline - 1% higher.

Higher Hemoglobin A1c (HbA1) Associated with Treatment Choice at Baseline

Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

Older age Associated with Treatment Choice at Baseline

Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No

All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.

Disinhibited Eating Associated with Treatment Choice at Baseline

Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

Higher Random Glucose Associated with Treatment Choice at Baseline

Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week  over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

Blood glucose self-monitoring - 1 test/week more

Frequent Blood Glucose self monitoring Associated with Treatment Choice at Baseline

Missing

Unknown

Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

Receipt of diet/exercise advice - Yes vs. No

Diet and Exercise Advice in Diabetes Management Associated with Treatment Choice at Baseline

Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

LDL cholesterol - 1 mmol/L higher at baseline

Higher Value of Low Density Lipoprotein Cholesterol Associated with Treatment Choice at Baseline

Changes in HbA1c From Baseline to Month 24

Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24.
Only patients with baseline HbA1c >= 7.0 % were included in this analysis

Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24.
Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24

Changes in Weight From Baseline to Month 24

Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months

Incidence of Hypoglycemia between Baseline and 24 Months

Inadequate response

Adverse event

Patient decision

Non compliance

Cannot afford medication

Other

Reasons for Discontinuation of Baseline Regimen

HbA1c (%) at baseline

DHP barriers to activity subscale at baseline

Gastrointestinal symptoms:  yes vs. no at baseline

Insulin regimen:  basal/bolus vs. long-acting only

Insulin regimen:  mixtures vs. long-acting only

Insulin regimen:  other vs. long-acting only

Insulin regimen:  short-acting only vs. long-actin

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort

Insulin regimen:  short-acting only vs. long-acting only

Factors Associated with Treatment Change in Insulin Cohort

Gastro intestinal symptoms:  yes vs no at baseline

EQ-5D index value at baseline

Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).

Factors Associated with Treatment Change in Exenatide BID Cohort

Last 6 months prior to baseline

Baseline to 24 months

Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months

Number of contacts with Health Care Providers Between Baseline and 24 Months

Percentage of Patients Hospitalized Between Baseline and 24 Months

Overall Study

2515 patients enrolled. 2388 patients in final analysis (22 not in either cohort), excluded: 92 had no investigator signature on summary  page, 11 had no treatment start date, 2 had issues with their informed consent to release their data.

Arms	Assigned Interventions
1 exenatide	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: Byetta
2 insulin	-

CHOICE: CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy

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