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

June 24, 2008 updated by: Daiichi Sankyo, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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..

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • Antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
placebo
Drug: placebo
placebo
ACTIVE_COMPARATOR: 1
Colesevelam hydrochloride
Drug: Colesevelam hydrochloride
Welchol tablet 625mg
Other Names:
  • Welchol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks
To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement.
Time Frame: 8 weeks
8 weeks
To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Investigators

  • Study Director: Director Clinical Development, Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (ESTIMATE)

August 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2008

Last Update Submitted That Met QC Criteria

June 24, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEL-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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