Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00361153

Purpose

This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Colesevelam hydrochloride Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus

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 evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	May 2006
Study Completion Date:	March 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Colesevelam hydrochloride	Drug: Colesevelam hydrochloride Welchol tablet 625mg
2: Placebo Comparator placebo	Drug: placebo placebo

Detailed Description:

Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind colesevelam or placebo. A screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one with colesevelam, and one OGTT at the end of the treatment period..

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:

Have given written informed consent
Ages 18 to 75 years, inclusive
Diagnosis of type 2 diabetes mellitus of at least 3 months duration
HbA1C 7.0- 10.0%, inclusive
Antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization
Women may be enrolled if they are not pregnant (negative serum βHCG at the Screening Visit), are not breast-feeding, and do not plan to become pregnant during the trial. In addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. An acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, and partner's vasectomy are NOT acceptable methods of contraception
BMI 25 - 45 kg/M sq, inclusive

Exclusion Criteria:

Subjects are excluded from participation in the study if any of the following criteria apply:

Type 1 diabetes mellitus or history of diabetic ketoacidosis
Treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization
Treatment with WelChol, cholestyramine or colestipol for hyperlipidemia within the last 3 months
Treatment with thiazolidinediones
History of dysphagia, swallowing disorders, or intestinal motility disorder
Serum triglyceride >500 mg/dL at Visit 1
Serum LDL-C <60 mg/dL at Visit 1
Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
Use of any investigational drug within 30 days before randomization
Chronic treatment with oral corticosteroids
History of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361153

Locations

United States, Texas
Diabetes and Glandular Research Associates
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Director:

Director Clinical Development

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo ( Vice President Clinical Development )
Study ID Numbers:	WEL-202
Study First Received:	August 3, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00361153 History of Changes
Health Authority:	United States: Food and Drug Administration

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 22, 2009