Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
- Registration Number
- NCT00359762
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1029
- Diagnosed with type 2 diabetes mellitus.
- Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
- HbA1c >=6.5% and <=9.0%.
- Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
- Characteristics contraindicating metformin or glimepiride use.
- Receiving drugs that directly affect gastrointestinal motility.
- Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors; *sulfonylurea; *meglitinides
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide exenatide - Glimepiride glimepiride -
- Primary Outcome Measures
Name Time Method Number of Patients With Treatment Failure Baseline to end of Period II (up to 4.5 years) Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
Time to Treatment Failure Baseline to end of Period II (up to 4.5 years) Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.
- Secondary Outcome Measures
Name Time Method Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3 Year 3 in Period II HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).
Change in DI30/DG30 Ratio From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change in DI30/DG30 ratio from baseline to endpoint.
Disposition Index at Year 3 Year 3 in Period II Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).
Triglycerides at Year 3 Year 3 in Period II Triglycerides at Year 3.
Total Cholesterol at Year 3 Year 3 in Period II Total Cholesterol at Year 3.
High-density Lipoprotein (HDL) Cholesterol at Year 3 Year 3 in Period II HDL Cholesterol at Year 3.
Hypoglycemia Rate Per Year Baseline to end of Period II (up to 4.5 years) All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III Baseline in Period III, Year 2 in Period III Change in HbA1c from baseline to Year 2.
Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III Baseline in Period III, Year 2 in Period III Change in HbA1c from baseline to Year 2.
Hypoglycemia Rate Per Year in Period III Start of Period III to end of study All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.
Change in HOMA-B From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change in HOMA-B from baseline to endpoint.
Fasting Proinsulin/Insulin Ratio at Year 3 Year 3 in Period II Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.
Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint. Baseline, end of Period II (up to 4.5 years) Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.
Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3 Year 3 in Period II DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).
Change in Disposition Index From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change in disposition index from baseline to endpoint.
Change in HbA1c From Baseline to Year 3 Baseline, Year 3 in Period II Change in HbA1c from baseline to Year 3.
Change in HbA1c From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).
Fasting Plasma Glucose at Year 3 Year 3 in Period II Fasting plasma glucose at Year 3.
Change in Fasting Plasma Glucose From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change in fasting plasma glucose from baseline to endpoint.
Postprandial (2 Hours) Plasma Glucose at Year 3 Year 3 in Period II Postprandial (2 hours) plasma glucose at Year 3.
Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint Baseline, end of Period II (up to 4.5 years) Change from baseline in postprandial (2 hours) plasma glucose to endpoint.
Change in Body Weight From Baseline to Year 3 Baseline, Year 3 in Period II Change in Body weight from baseline to Year 3.
Systolic Blood Pressure at Year 3 Year 3 in Period II Systolic Blood pressure at Year 3.
Diastolic Blood Pressure at Year 3 Year 3 in Period II Diastolic Blood pressure at Year 3.
Heart Rate at Year 3 Year 3 in Period II Heart rate at Year 3.
Trial Locations
- Locations (1)
Research Site
🇬🇧Wiltshire, United Kingdom