WelChol® With Metformin in Treating Patients With Type 2 Diabetes

January 16, 2012 updated by: Daiichi Sankyo, Inc.

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents

The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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

  • Mexico
      • Mexico DF, Mexico
  • Peru
      • Lima, Peru
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States
        • cro
    • California
      • Beverly Hills, California, United States
      • Carmichael, California, United States
      • Fresno, California, United States
      • Irvine, California, United States
      • La Jolla, California, United States
      • Los Gatos, California, United States
      • San Diego, California, United States
      • Spring Valley, California, United States
      • West Hills, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Coco Beach, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Pembroke Pines, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Indiana
      • Evansville, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Michigan
      • Detroit, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Edina, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • Montana
      • Bozeman, Montana, United States
      • Butte, Montana, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Tennessee
      • Morristown, Tennessee, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Pharr, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Arlington, Virginia, United States
      • Richmond, Virginia, 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Hemoglobin (HbA1c) between 7.5% to 9.5%
  • Prescribed an ADA accepted diet
  • Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
  • History of pancreatitis
  • Uncontrolled hypertension
  • Recent severe cardiovascular disease
  • Allergy or toxic response to colesevelam or any of its components
  • Body mass index (BMI) >45 kg/m2

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures

Outcome Measure
To assess the fasting plasma glucose and fructosamine lowering effect;
To assess the glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEL-301

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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