A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease
Overview
- Phase
- Phase 3
- Intervention
- placebo
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2118
- Primary Endpoint
- Time to cardiovascular composite primary endpoints
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
placebo
Intervention: placebo
taspoglutide
Intervention: taspoglutide
Outcomes
Primary Outcomes
Time to cardiovascular composite primary endpoints
Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Secondary Outcomes
- 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)