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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00147719

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 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 Metformin Monotherapy or Metformin 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 Metformin Metformin hydrochloride

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 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

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

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

Show 48 Study Locations

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):

Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83.

Study ID Numbers:	WEL-301
Study First Received:	September 2, 2005
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00147719 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

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Colesevelam
Antilipemic Agents
Metformin
Diabetes Mellitus
Endocrine System Diseases

Anticholesteremic Agents
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Colesevelam
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Metformin
Physiological Effects of Drugs
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on July 02, 2009