Status:
COMPLETED
Effect on Weight Loss of Exenatide Versus Placebo
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 inad...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00375492
Start Date
September 1 2006
End Date
February 1 2008
Last Update
April 7 2015
Active Locations (10)
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1
Research Site
Peoria, Arizona, United States
2
Research Site
Jacksonville, Florida, United States
3
Research Site
Orlando, Florida, United States
4
Research Site
Indianapolis, Indiana, United States