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
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Hyperlipidemia
Intervention: Colesevelam HCl (Drug); rosiglitazone maleate (Drug); sitagliptin phosphate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
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.
Clinical Details
Official title: Effects of Colesevelam HCl, AvandiaŽ (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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Secondary outcome: Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares MeanMean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean Mean Change in FPG From Week 0(Baseline) to Week 8 Mean Change in FPG From Week 0(Baseline) to Week 16 Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean Mean Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Mean Change in Post-Prandial Insulin From Week 0(Baseline) to Week 16 Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean Mean Change in LDL-C From Week 0(Baseline) to Week 16 Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
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
La Mesa, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
San Antonio, California, United States
Chiefland, Florida, United States
Gary, Indiana, United States
Baltimore, Maryland, United States
Dearborn, Michigan, United States
W. Bloomfield, 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
Last updated: June 17, 2009
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