A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
- Registration Number
- NCT01018173
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2118
Inclusion Criteria
- adult patients, >18 years of age
- diabetes mellitus type 2
- HbA1c >/=6.5% and </=10% at screening
- BMI >/=23kg/m2
- cardiovascular disease with onset >/=1 month prior to screening
Exclusion Criteria
- diagnosis or history of type 1 diabetes or secondary forms of diabetes
- acute metabolic diabetic complications within past 6 months
- severe hypoglycemia </=1 month prior to screening
- clinically significant gastrointestinal disease
- history of chronic or acute pancreatitis
- current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
- severely impaired renal function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - taspoglutide taspoglutide -
- Primary Outcome Measures
Name Time Method Time to cardiovascular composite primary endpoints event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
- Secondary Outcome Measures
Name Time Method Secondary cardiovascular composite endpoints event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter Individual components of primary cardiovascular composite endpoints event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter Total mortality assessed at end of study, week 104 Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR) laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter