A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients, >18 years of age

• diabetes mellitus type 2

• HbA1c >/=6.5% and
• 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
• 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