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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361153
First Posted: August 7, 2006
Last Update Posted: June 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Daiichi Sankyo, Inc.
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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 ]

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

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
Active Comparator: 1
Colesevelam hydrochloride
Drug: Colesevelam hydrochloride
Welchol tablet 625mg
Other Name: Welchol
Placebo Comparator: 2
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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vice President Clinical Development, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00361153     History of Changes
Other Study ID Numbers: WEL-202
First Submitted: August 3, 2006
First Posted: August 7, 2006
Last Update Posted: June 25, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Colesevelam Hydrochloride
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents