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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Ponte Verde, Florida 32081, United States
Freemantle, Queensland 6959, Australia
Ricany U Prahy, 250 01, Czechia
Viljandimaa, 71024, Estonia
Banglore, 560034, India
Kelantan, 16150, Malaysia
Juarez, Distrito Federal, 6600, Mexico
S. Petersburg, 194291, Russia
Observatory, Cape Town, 7925, South Africa
Taoyuan County, 333, Taiwan