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

 -  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