Status:
COMPLETED
Exenatide Versus Glimepiride in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes mellitus.
- Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
- HbA1c \>=6.5% and \<=9.0%.
- Body Mass Index (BMI) \>=25 kg/m\^2 and \<40 kg/m\^2.
Exclusion
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
- Characteristics contraindicating metformin or glimepiride use.
- Receiving drugs that directly affect gastrointestinal motility.
- Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: \*insulin; \*thiazolidinediones; \*alpha-glucosidase inhibitors; \*sulfonylurea; \*meglitinides
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1029 Patients enrolled
Trial Details
Trial ID
NCT00359762
Start Date
September 1 2006
End Date
March 1 2011
Last Update
September 15 2015
Active Locations (114)
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1
Research Site
Graz, Austria
2
Research Site
Innsbruck, Austria
3
Research Site
Salzburg, Austria
4
Research Site
Vienna, Austria