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

Sponsor:	Daiichi Sankyo Inc.
Information provided by (Responsible Party):	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:	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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

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
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

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 ClinicalTrials.gov Identifier (NCT Number):

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.

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 February 12, 2012