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 |
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.
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
We found this trial at
72
sites
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