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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colesevelam
Colesevelam matching placebo
Insulin glargine (Lantus)
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mechanism of action insulin sensitivity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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greater than or equal to 8.0% Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn) Overweight, obese (body mass index 25-45 kg/m2) Exclusion Criteria: Change of dose of lipid or blood pressure lowering therapy within past three months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

Sites / Locations

  • San Diego VMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

colesevelam 3.8g administered daily for 12 weeks

Colesevelam matching placebo for 12 weeks

open-label Insulin Glargine for 12 weeks

Outcomes

Primary Outcome Measures

Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
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.
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
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
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
The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.

Full Information

First Posted
September 2, 2005
Last Updated
March 5, 2014
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00147745
Brief Title
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Official Title
Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Mechanism of action insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
colesevelam 3.8g administered daily for 12 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Colesevelam matching placebo for 12 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
open-label Insulin Glargine for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Colesevelam
Intervention Description
Colesevelam 3.8g for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Colesevelam matching placebo
Intervention Description
Colesevelam matching placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (Lantus)
Intervention Description
Insulin glargine for 12 weeks
Primary Outcome Measure Information:
Title
Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
Description
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.
Time Frame
Baseline to 12 weeks
Title
Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.
Description
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.
Time Frame
Baseline to 12 weeks
Title
Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose
Description
Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.
Time Frame
Baseline (Day -4) to first dose (Day 1)
Secondary Outcome Measure Information:
Title
The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks
Description
The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
San Diego VMC
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

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

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