WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00147758

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Colesevelam GT31-104

U.S. FDA Resources

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 efficacy;
To assess glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on C reactive protein;
To assess lipids and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

Estimated Enrollment:	400
Study Start Date:	June 2004

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147758

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Locations

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

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 National Clinical Trials Identifier (NCT ID):

Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. Epub 2008 May 5.

Study ID Numbers:	WEL-303
Study First Received:	September 2, 2005
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00147758 History of Changes
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:

Antimetabolites
Colesevelam
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Anticholesteremic Agents
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009