WelChol® With Metformin in Treating Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00147719
First received: September 2, 2005
Last updated: January 16, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Colesevelam hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: June 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147719

  Hide Study Locations
Locations
United States, Arkansas
CRO
Jonesboro, Arkansas, United States
United States, 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
United States, District of Columbia
Washington, District of Columbia, United States
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
United States, Georgia
Atlanta, Georgia, United States
United States, Indiana
Evansville, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Michigan
Detroit, Michigan, United States
Troy, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, Montana
Bozeman, Montana, United States
Butte, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Beaver, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, Tennessee
Morristown, Tennessee, United States
United States, Texas
Corpus Christi, Texas, United States
Dallas, Texas, United States
Pharr, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Arlington, Virginia, United States
Richmond, Virginia, United States
Mexico
Mexico DF, Mexico
Peru
Lima, Peru
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00147719     History of Changes
Other Study ID Numbers: WEL-301
Study First Received: September 2, 2005
Last Updated: January 16, 2012
Health Authority: United States: Food and Drug Administration
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Daiichi Sankyo Inc.:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Metformin
Colesevelam
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014