A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,118 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal