Status:
COMPLETED
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00324363
Start Date
January 1 2006
End Date
April 1 2007
Last Update
February 23 2015
Active Locations (14)
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1
Research Site
Beijing, China
2
Research Site
Guangzhou, China
3
Research Site
Nanjing, China
4
Research Site
Shanghai, China