A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
- Registration Number
- NCT00909597
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 756
Inclusion Criteria
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus;
- treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
- HbA1c >=7.0% and <=10% at screening;
- stable weight +/-5% for >=12 weeks prior to screening.
Exclusion Criteria
- type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
- clinically significant diabetic complications;
- clinically symptomatic gastrointestinal disease;
- >3 episodes of severe hypoglycemia within 6 months before screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description taspoglutide 10mg/20mg taspoglutide taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly taspoglutide 10mg taspoglutide taspoglutide 10mg sc weekly pioglitazone pioglitazone -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in HbA1c 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse events; laboratory parameters; cardiovascular events At each clinic visit up to 106 weeks Proportion of patients achieving target HbA1c <=6.5%, <=7% weeks 24, 52 and 104 Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose weeks 24, 52 and 104