Overview

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