Status:
COMPLETED
Safety and Efficacy of Exenatide as Monotherapy
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Have previously completed or withdrawn from this study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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00381342
Start Date
September 1 2006
End Date
September 1 2007
Last Update
February 23 2015
Active Locations (19)
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1
Research Site
Idaho Falls, Idaho, United States
2
Research Site
Indianapolis, Indiana, United States
3
Research Site
Aligarh, India
4
Research Site
Bangalore, India