Effects of Three Drugs (Colesevelam HCl, Rosiglitazone, and Sitagliptin) on Control of Blood Glucose and Lipids (e.g., Cholesterol) Will be Examined in Patients With Type 2 Diabetes Whose Blood Glucose is Not Completed Controlled With the Diabetes Drug Metformin
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Hyperlipidemia
Intervention: Colesevelam HCl (Drug); colesevelam tablets (Drug); rosiglitazone (Drug); sitagliptin phosphate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Daiichi Sankyo Inc.
Summary
A 16 week open-label study with subjects receiving background metformin monotherapy. The 150
subjects will be randomized 1: 1:1 to receive of the following: open-label colesevelam HCl,
open label rosiglitazone, or open-label sitagliptin.
Clinical Details
Official title: Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in HbA1c from baseline to Week 16 endpoint
Secondary outcome: Change in HbA1c from baseline to week 8; change in FPG from baseline to weeks 8 and 16; Change in fasting insulin levels from baseline to weeks 8 and 16
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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- HbA1C 7. 0 % to 10. 0% on metformin monotherapy; may be withdrawn from other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.
Locations and Contacts
San Antonio, California, United States
Los Gatos, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Chiefland, Florida, United States
Gary, Indiana, United States
Baltimore, Maryland, United States
W. Bloomfield, Michigan, United States
Dearborn, Michigan, United States
Las Vegas, Nevada, United States
Yonkers, New York, United States
Lexington, North Carolina, United States
Winston-Salem, North Carolina, United States
Munroe Falls, Ohio, United States
Zaneville, Ohio, United States
Portland, Oregon, United States
Jersey Shore, Pennsylvania, United States
Clemson, South Carolina, United States
Harriman, Tennessee, United States
Dallas, Texas, United States
Additional Information
Starting date: May 2007
Ending date: May 2008
Last updated: April 9, 2008
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