Overview
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
Status:
Completed
Completed
Trial end date:
2008-04-01
2008-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.Treatments:
Colesevelam Hydrochloride
Maleic acid
Metformin
Rosiglitazone
Sitagliptin Phosphate
Criteria
Inclusion Criteria:- HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other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.
Exclusion Criteria:
- Subjects currently treated with a thiazolidinedione are excluded.