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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT01018173

Run by

Hoffmann-La Roche

People needed

2118

Starts

2010-01-01

Expected to finish

2011-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Buena Park, California, United States
• Study site — Calabasas, California, United States
• Study site — Fresno, California, United States
• Study site — Santa Ana, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ponte Verde, Florida, United States
• Study site — Bloomingdale, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Oxon Hill, Maryland, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — North Platte, Nebraska, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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