Status:
COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patient...
Eligibility Criteria
Inclusion
- adult patients, 18-80 years of age;
- drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
- C-peptide (fasting) \>=1.0ng/mL
- HbA1c \>=6.5% and \<=10.0% at screening;
- BMI \>=25 (\>23 for Asians) and \<=45kg/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;
- symptomatic poorly controlled diabetes;
- 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 :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00744926
Start Date
August 1 2008
End Date
April 1 2010
Last Update
July 28 2016
Active Locations (58)
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1
Phoenix, Arizona, United States, 85015
2
Los Angeles, California, United States, 90057
3
Santa Ana, California, United States, 92701
4
Avon, Indiana, United States, 46123