DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Mean

Mean 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017