Status:
COMPLETED
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
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 to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with met...
Eligibility Criteria
Inclusion
- adult patients, 18-75 years of age;
- type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
- C-peptide (fasting) \>=1.0ng/mL;
- HbA1c \>=7.0% 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;
- 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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
1072 Patients enrolled
Trial Details
Trial ID
NCT00755287
Start Date
November 1 2008
End Date
December 1 2010
Last Update
July 29 2016
Active Locations (210)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix, Arizona, United States, 85032
2
Searcy, Arkansas, United States, 72143
3
Concord, California, United States, 94520
4
Huntington Beach, California, United States, 92648