Safety and Efficacy of Exenatide as Monotherapy
- Registration Number
- NCT00381342
- Lead Sponsor
- AstraZeneca
- Brief Summary
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
- Diagnosed with type 2 diabetes
- Treating diabetes with diet and exercise
- HbA1c between 6.5% and 10.0%, inclusive
- Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
- Have previously completed or withdrawn from this study
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Have been treated with any antidiabetic agent
- Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Placebo in volumes equivalent to exenatide Exenatide 5 mcg/exenatide 10 mcg exenatide Exenatide 5 mcg, then exenatide 10 mcg Exenatide 5 mcg/exenatide 5 mcg exenatide Exenatide 5 mcg; then exenatide 5 mcg
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 Baseline, Week 24 Change in HbA1c from Baseline to Week 24
- Secondary Outcome Measures
Name Time Method Change in body weight from Baseline to Week 24 Baseline, Weeks 4, 8, 12, 16, and 24 Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less Baseline, Weeks 4, 8, 12, 16, 24 Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Change in glucose measurements from Baseline to Week 24 Baseline, Weeks 4, 8, 12, 16, 24 Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between
Change in fasting serum glucose (FSG) from Baseline to Week 24 Baseline, Weeks 4, 8, 12, 16, and 24 Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 Baseline, Weeks 4, 8, 12, 16, and 24 Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between
Changes in fasting and 30, 60, 120 and 180-minute glucose measurements Immediately before glucose load, then 30, 60, 120, and 180 minutes post Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin
Trial Locations
- Locations (1)
Research Site
🇷🇺St. Petersburg, Russian Federation