A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
- Registration Number
- NCT00823992
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description taspoglutide taspoglutide - placebo placebo -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in HbA1c 24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in body weight;% of patients achieving >=5% weight loss 24 weeks Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n At planned clinic visits, for 12 months % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function 24 weeks