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

Sponsored by:	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

Show 47 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):

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

Study placed in the following topic categories:

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

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

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 July 02, 2009