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

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.
 
ClinicalTrials.gov Identifier: NCT00147745
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : December 4, 2009
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Results First Submitted Date  ICMJE July 15, 2009
Results First Posted Date  ICMJE December 4, 2009
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE June 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • 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 ]
    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 ]
    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) ]
    Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • - To evaluate the effect of WelChol® on hepatic insulin sensitivity
  • - To evaluate the acute effect of WelChol®, single or multi
  • dose, on oral glucose absorption
Change History Complete list of historical versions of study NCT00147745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    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 ]
    The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • - To evaluate the acute effect of WelChol®, single or multi
  • dose, on oral glucose absorption
  • - To evaluate the effect of WelChol® on hemoglobin A1c
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Official Title  ICMJE Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Colesevelam
    Colesevelam 3.8g for 12 weeks
  • Drug: Colesevelam matching placebo
    Colesevelam matching placebo for 12 weeks
  • Drug: Insulin glargine (Lantus)
    Insulin glargine for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    colesevelam 3.8g administered daily for 12 weeks
    Intervention: Drug: Colesevelam
  • Placebo Comparator: 2
    Colesevelam matching placebo for 12 weeks
    Intervention: Drug: Colesevelam matching placebo
  • Active Comparator: 3
    open-label Insulin Glargine for 12 weeks
    Intervention: Drug: Insulin glargine (Lantus)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2009)
36
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
45
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147745
Other Study ID Numbers  ICMJE WEL-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP