Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
- Registration Number
- NCT00103935
- Lead Sponsor
- AstraZeneca
- Brief Summary
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
- Has HbA1c of 7.1% to 11.0%, inclusive.
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
- Received any investigational drug within 3 months prior to screening.
- Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
- Participated previously in an exenatide clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A2 placebo Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR Group C Exenatide LAR Exenatide lead-in followed by exenatide LAR 2.0 mg weekly Group A1 placebo Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR Group B Exenatide LAR Exenatide lead-in followed by exenatide LAR 0.8 mg weekly
- Primary Outcome Measures
Name Time Method Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM) Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours
- Secondary Outcome Measures
Name Time Method Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus Various time intervals from Day 1 to Week 15 Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27). Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 Change in HbA1c from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination.
Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 Change in fasting glucose concentrations from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 Change in body weight (kg) from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15 Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15 Change in seven-point glucose concentrations from baseline (collected on 3 days between Visit 2 \[Day -7\] and Visit 3 \[Day -3\]) to Visit 25 (collected on 3 days between Visit 20 \[Week 14\] and Visit 25 \[Week 15\])
Trial Locations
- Locations (1)
Research Site
🇺🇸Olympia, Washington, United States