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.
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 6/3/2016 |
Start Date: | November 2008 |
End Date: | March 2011 |
A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
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 metformin and sulphonylurea combination therapy. Patients will be randomized
to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition
to continued prestudy metformin treatment. The anticipated time on study treatment is 2+
years, and the target sample size if 500+ individuals.
to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately
controlled with metformin and sulphonylurea combination therapy. Patients will be randomized
to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition
to continued prestudy metformin treatment. The anticipated time on study treatment is 2+
years, and the target sample size if 500+ individuals.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
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