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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Colesevelam; Drug: Insulin glargine (Lantus); Drug: Colesevelam matching placebo

• Registration Number: NCT00147745
• Lead Sponsor: Daiichi Sankyo

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 available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-07-15
• Results First Submitted QC: 2009-11-03
• Results First Posted: 2009-12-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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• Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Colesevelam	colesevelam 3.8g administered daily for 12 weeks
3	Insulin glargine (Lantus)	open-label Insulin Glargine for 12 weeks
2	Colesevelam matching placebo	Colesevelam matching placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.	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.	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	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.

Secondary Outcome Measures

Name	Time	Method
The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks	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	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.

Trial Locations

Locations (1)

San Diego VMC; 🇺🇸 San Diego, California, United States