Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes, but otherwise healthy

• HbA1c between 6.6% and 9.5%, inclusive.

• Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.

• Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion Criteria:

• Patients previously in a study using exenatide.

• Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).

• Treated with insulin within 3 months of screening.