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WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147758
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
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 sulfonylurea alone or in combination with other anti-diabetic drugs.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Colesevelam hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents
Study Start Date : June 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures :
  1. To assess the fasting plasma glucose and fructosamine lowering efficacy;
  2. To assess glycemic control response rate;
  3. To assess the improvement in insulin sensitivity;
  4. To assess the effect on C reactive protein;
  5. To assess lipids and lipoproteins;
  6. To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
  • Hemoglobin A1c value 7.5% to 9.5%, inclusive
  • C peptide > 0.5 ng/mL
  • Prescribed ADA diet

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of pancreatitis
  • Uncontrolled hypertension
  • Allergy or toxic response to colesevelam or any of its components
  • Serum LDL-C < 60 mg/dL
  • Serum TG > 500 mg/dL
  • Body mass index (BMI) > 45 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147758

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United States, Alabama
Birmingham, Alabama, United States
Tuscumbia, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
United States, California
Concord, California, United States
Irvine, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
West Hills, California, United States
United States, Florida
Coral Gables, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
St. Louis, Missouri, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Marion, Ohio, United States
Perrysburg, 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
United States, Tennessee
Bristol, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Arlington, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Lakewood, Washington, United States
Renton, Washington, United States
Mexico DF, Mexico
Lima, Peru
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00147758    
Other Study ID Numbers: WEL-303
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Daiichi Sankyo, Inc.:
Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents