Status:
COMPLETED
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidin...
Eligibility Criteria
Inclusion
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c \>=7.0% and \<=10% at screening;
- BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1189 Patients enrolled
Trial Details
Trial ID
NCT00717457
Start Date
July 1 2008
End Date
March 1 2011
Last Update
November 2 2016
Active Locations (216)
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1
Haleyville, Alabama, United States, 35565
2
Mobile, Alabama, United States, 36617
3
Montgomery, Alabama, United States, 36106
4
Tuscaloosa, Alabama, United States, 35406