Status:
COMPLETED
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones 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, as measured by hemoglobin ...
Eligibility Criteria
Inclusion
- Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.
Exclusion
- Patient previously in a study using exenatide or GLP-1 analogs.
- Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
- Treated with oral insulin within 3 months of screening.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00099320
Start Date
May 1 2004
End Date
August 1 2005
Last Update
February 23 2015
Active Locations (51)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
La Jolla, California, United States
3
Research Site
San Mateo, California, United States
4
Research Site
Santa Barbara, California, United States