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

August 23, 2016 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: colesevelam
colesevelam tablets 625 mg
Drug: Colesevelam HCl
coleveselam tablets 625 mg; 6 tablets/day
Active Comparator: rosiglitazone
rosiglitazone maleate 4mg
Drug: rosiglitazone maleate
rosiglitazone tablets 4mg
Active Comparator: sitagliptin
sitagliptin phosphate tablets
Drug: sitagliptin phosphate
sitagliptin phosphate tablets 100mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Time Frame: 16 weeks change = week 16 - week 0.
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
Time Frame: 16 weeks change = week 16 - week 0.
Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
Time Frame: 8 weeks change = week 8- week 0.
change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.
8 weeks change = week 8- week 0.
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
Time Frame: 8 weeks change = week 8- week 0.
change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
8 weeks change = week 8- week 0.
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
Time Frame: 16 weeks change = week 16 - week 0.
change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Change in FPG From Week 0(Baseline) to Week 8
Time Frame: 8 weeks change = week 8- week 0.
mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.
8 weeks change = week 8- week 0.
Mean Change in FPG From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
Time Frame: 8 weeks change = week 8- week 0.
change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
8 weeks change = week 8- week 0.
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
Time Frame: 16 weeks change = week 16 - week 0.
change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
Time Frame: 8 weeks change = week 8- week 0.
mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
8 weeks change = week 8- week 0.
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
Time Frame: 16 weeks change = week 16 - week 0.
change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
Time Frame: 16 weeks change = week 16 - week 0.
change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Change in LDL-C From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
Time Frame: 16 weeks change = week 16 - week 0.
mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
Time Frame: 16 weeks change = week 16 - week 0.
percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
16 weeks change = week 16 - week 0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wel-409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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