Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00147745
First received: September 2, 2005
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes
Drug: Colesevelam
Drug: Colesevelam matching placebo
Drug: Insulin glargine (Lantus)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.

  • Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.

  • Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose [ Time Frame: Baseline (Day -4) to first dose (Day 1) ] [ Designated as safety issue: No ]
    Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.


Secondary Outcome Measures:
  • The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.

  • Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.


Enrollment: 36
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
colesevelam 3.8g administered daily for 12 weeks
Drug: Colesevelam
Colesevelam 3.8g for 12 weeks
Placebo Comparator: 2
Colesevelam matching placebo for 12 weeks
Drug: Colesevelam matching placebo
Colesevelam matching placebo for 12 weeks
Active Comparator: 3
open-label Insulin Glargine for 12 weeks
Drug: Insulin glargine (Lantus)
Insulin glargine for 12 weeks

  Eligibility

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

Inclusion Criteria:

  • Patients between the ages of 18 - 75, inclusive
  • Diagnosed with type 2 diabetes
  • Hemoglobin A1c value greater than or equal to 8.0%
  • Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
  • Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

  • Change of dose of lipid or blood pressure lowering therapy within past three months
  • Previous treatment with colesevelam for hyperlipidemia
  • Serum triglyceride greater than 500 mg/dL
  • Serum low density lipoprotein-cholesterol less than 60 mg/dL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147745

Locations
United States, California
San Diego VMC
San Diego, California, United States, 92161
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00147745     History of Changes
Other Study ID Numbers: WEL-201
Study First Received: September 2, 2005
Results First Received: July 15, 2009
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Mechanism of action insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Colesevelam
Hypoglycemic Agents
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 August 19, 2014