Status:
COMPLETED
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 measu...
Eligibility Criteria
Inclusion
- 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
- 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- Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00434954
Start Date
February 1 2007
End Date
June 1 2009
Last Update
April 7 2015
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Bad Mergentheim, Germany
2
Research Site
Berlin, Germany
3
Research Site
Bosenheim, Germany
4
Research Site
Burghausen, Germany