Status:
COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
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 of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone,...
Eligibility Criteria
Inclusion
- adult patients, 18-75 years age;
- type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening;
- HbA1c \>=7.0% and \<=10.0% at screening;
- BMI \>= 25 (\>23 for Asians) and \<=45 kg/m2 at screening;
- stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- clinically symptomatic gastrointestinal disease;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00744367
Start Date
October 1 2008
End Date
November 1 2010
Last Update
August 5 2016
Active Locations (113)
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1
Birmingham, Alabama, United States, 35209
2
Birmingham, Alabama, United States, 35294
3
Huntsville, Alabama, United States, 35801
4
Muscle Shoals, Alabama, United States, 35661