Status:
COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherap...
Eligibility Criteria
Inclusion
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
- HbA1c \>=6.5% and \<=9.5% at screening;
- BMI \>=30 and \<=50 kg/m2 at screening;
- stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion
- history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
- evidence of clinically significant diabetic complications;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00823992
Start Date
January 1 2009
End Date
May 1 2010
Last Update
July 28 2016
Active Locations (71)
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1
Bermuda Dunes, California, United States, 92203
2
La Jolla, California, United States, 92037
3
Los Angeles, California, United States, 90057
4
Mission Viejo, California, United States, 92691