Safety and Efficacy of Exenatide as Monotherapy

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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 and exercise.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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 Criteria:

• Have previously completed or withdrawn from this study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