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

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00151749

Purpose

The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-Diabetic Agents

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin 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 WelChol® to current antidiabetic therapy

Secondary Outcome Measures:

To assess: the effects on fasting plasma glucose and
fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
on therapy to patients receiving insulin alone or with
other oral drugs

Estimated Enrollment:	260
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:

Ages 18 - 75 years, inclusive
Diagnosed with type 2 diabetes
Stable insulin therapy for 6 weeks
Stable dose of any other antidiabetic medications for 90 days
Hemoglobin A1c value between 7.5% to 9.5%
C peptide greater than 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 less than 60 mg/dL
Serum TG greater than 500 mg/dL
Body mass index (BMI) greater than 45 kg/m2-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151749

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Locations

United States, Alabama

Tuscumbia, Alabama, United States
United States, Arizona

Sierra Vista, Arizona, United States
United States, Arkansas

Jonesboro, Arkansas, United States

Searcy, Arkansas, United States
United States, California

Carmichael, California, United States

Concord, California, United States

Fullerton, California, United States

La Jolla, California, United States

San Diego, California, United States

West Hills, California, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Largo, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

West Palm Beach, Florida, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Kentucky

Lexington, Kentucky, United States

Louisville, Kentucky, United States
United States, Louisiana

New Orleans, Louisiana, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Michigan

Troy, Michigan, United States
United States, Minnesota

Edina, Minnesota, United States
United States, Missouri

Chesterfield, Missouri, United States

Kansas City, Missouri, United States

St. Louis, Missouri, United States
United States, Montana

Bozeman, Montana, United States

Butte, Montana, United States
United States, New Jersey

Englewood, New Jersey, United States
United States, North Carolina

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Raleigh, North Carolina, United States

Statesville, North Carolina, United States

Winston-Salem, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States

Marion, Ohio, 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

Morristown, Tennessee, United States
United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

Midland, Texas, United States

San Antonio, Texas, 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):

Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40.

Study ID Numbers:	WEL-302
Study First Received:	September 7, 2005
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00151749 History of Changes
Health Authority:	United States: Food and Drug Administration; 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 27, 2009