WelChol® and Insulin 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:	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 3

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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy 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: Insulin human Colesevelam 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 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
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (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:

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 ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00151749 History of Changes
Other Study ID Numbers:	WEL-302
Study First Received:	September 7, 2005
Last Updated:	January 16, 2012
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:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
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 May 21, 2012