Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

Completed · Phase 3

Conditions studied: Type 2 Diabetes, Hyperlipidemia

In brief

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Key facts

Study ID

NCT00484419

Run by

Daiichi Sankyo

People needed

169

Starts

2007-05-01

Expected to finish

2008-04-01

Last updated by the study team

2016-10-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

You may not qualify if…

• Subjects currently treated with a thiazolidinedione are excluded.

Where it is running

• Study site — La Mesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — San Antonio, California, United States
• Study site — Chiefland, Florida, United States
• Study site — Gary, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Dearborn, Michigan, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Yonkers, New York, United States
• Study site — Lexington, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Munroe Falls, Ohio, United States
• Study site — Zaneville, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Jersey Shore, Pennsylvania, United States
• Study site — Clemson, South Carolina, United States
• Study site — Harriman, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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