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



Status:Completed
Conditions:Peripheral Vascular Disease, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:January 2010
End Date:January 2011

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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:

- 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
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