A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus Type 2

In brief

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00909597

Run by

Hoffmann-La Roche

People needed

756

Starts

2009-05-01

Expected to finish

2010-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus;
• treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
• HbA1c >=7.0% and <=10% at screening;
• stable weight +/-5% for >=12 weeks prior to screening.

You may not qualify if…

• type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
• clinically significant diabetic complications;
• clinically symptomatic gastrointestinal disease;
• >3 episodes of severe hypoglycemia within 6 months before screening.

Where it is running

• Study site — Chino, California, United States
• Study site — Los Angeles, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Roseville, California, United States
• Study site — Santa Ana, California, United States
• Study site — Chiefland, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Conyers, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Bethesda, Maryland, United States
• Study site — Ayer, Massachusetts, United States
• Study site — Buena Park, California, United States

Full record on ClinicalTrials.gov

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