Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: 2,4-thiazolidinedione; Exenatide; Metformin

Criteria

Inclusion Criteria:

• Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.

• HbA1c between 7.1% and 10.0%, inclusive.

• Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

• Patient previously in a study using exenatide or GLP-1 analogs.

• Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.

• Treated with oral insulin within 3 months of screening.