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Clinical Trial Details

Trial ID: L4343
Source ID: NCT00103935
Associated Drug: Placebo
Title: Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: placebo|DRUG: placebo|DRUG: Exenatide LAR|DRUG: Exenatide LAR
Outcome Measures: Primary: 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: 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)., 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., 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 to Week 15 and to each intermediate visit where applicable, and to study termination (Week 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, 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 from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 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, Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27|Change in seven-point glucose concentrations from Baseline to 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 \[Week 15\]), Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2005-02
Completion Date: 2005-10
Results First Posted:
Last Update Posted: 2015-02-24
Locations: Research Site, Walnut Creek, California, United States|Research Site, Honolulu, Hawaii, United States|Research Site, St. Louis, Missouri, United States|Research Site, Butte, Montana, United States|Research Site, Portland, Oregon, United States|Research Site, San Antonio, Texas, United States|Research Site, Olympia, Washington, United States
URL: https://clinicaltrials.gov/show/NCT00103935