Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

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

Summary

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

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

Details

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

Criteria

Main Inclusion Criteria:

• Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.

• HbA1c between 7.1% and 11.0%, inclusive.

• Insulin therapy should be the next appropriate step of diabetes treatment.

• Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

• Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.

• Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.