A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
- Registration Number
- NCT00717457
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1189
Inclusion Criteria
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c >=7.0% and <=10% at screening;
- BMI >=25kg/m2 (>23kg/m2 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, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exenatide exenatide - taspoglutide 10mg taspoglutide - taspoglutide 10mg/20mg taspoglutide -
- Primary Outcome Measures
Name Time Method Change in HbA1c 24 weeks
- Secondary Outcome Measures
Name Time Method Fasting body weight 24 weeks Proportion of patients reaching target HbA1c <=7.0%, <=6.5% 24 weeks Beta cell function (proinsulin/insulin ratio) 24 weeks Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. 24 weeks