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

• Status: Completed
• Trial end date: 2007-04-01
• 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.

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

Details

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

Criteria

Inclusion Criteria:

• Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.

• HbA1c between 7.1% and 11.0%, inclusive.

• Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

Exclusion Criteria:

• Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.

• Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.

• Have characteristics contraindicating metformin or sulfonylurea use.

• Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.

• Have used drugs for weight loss within 1 month of screening.