Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with type 2 diabetes mellitus.

• Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.

• HbA1c >=6.5% and <=9.0%.

• Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.

Exclusion Criteria:

• Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.

• Characteristics contraindicating metformin or glimepiride use.

• Receiving drugs that directly affect gastrointestinal motility.

• Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.

• Have used any prescription drug to promote weight loss within 3 months prior to screening.

• Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors; *sulfonylurea; *meglitinides