Effect on Weight Loss of Exenatide Versus Placebo
Completed · Phase 3 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.
Key facts
- Study ID
- NCT00375492
- Run by
- AstraZeneca
- People needed
- 196
- Starts
- 2006-09-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2015-04-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with type 2 diabetes for at least 6 months
- Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy
- Have an HbA1c of 6.6% to 10.0%, inclusive
- Have a Body Mass Index (BMI) of 25 kg/m\^2 to 39.9 kg/m\^2, inclusive
You may not qualify if…
- Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening
- Have conditions contraindicating metformin and/or sulfonylurea use
- Have had a change in lipid-lowering agents within 6 weeks of screening
- Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in 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
Where it is running
- Research Site — Peoria, Arizona, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Orlando, Florida, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Minneapolis, Minnesota, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Spartanburg, South Carolina, United States
- Research Site — San Antonio, Texas, United States
- Research Site — Renton, Washington, United States
Full record on ClinicalTrials.gov
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