Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin

Criteria

Inclusion Criteria:

• Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start

• Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start

• Have an HbA1c between 6.5% and 10.0%, inclusive

• Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive

Exclusion Criteria:

• Have type 1 diabetes or known latent autoimmune diabetes in adults

• Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start

• Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)

• Have used any prescription drug to promote weight loss within 3 months prior to study start

• Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry

• Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs