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

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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.


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.
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