A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/3/2016 |
| Start Date: | January 2009 |
| End Date: | January 2011 |
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
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 monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once
weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their
prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo
will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once
weekly) The anticipated time on study treatment is 12 months, and the target sample size is
100-500 individuals.
to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with
metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once
weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their
prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo
will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once
weekly) The anticipated time on study treatment is 12 months, and the target sample size is
100-500 individuals.
Inclusion Criteria:
- 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 Criteria:
- 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.
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