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

Daiichi Sankyo36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

ColesevelamDRUG

Colesevelam 3.8g for 12 weeks

Colesevelam matching placeboDRUG

Colesevelam matching placebo for 12 weeks

Insulin glargine (Lantus)DRUG

Insulin glargine for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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than or equal to 8.0% * Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn) * Overweight, obese (body mass index 25-45 kg/m2) Exclusion Criteria: * Change of dose of lipid or blood pressure lowering therapy within past three months *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

Locations (1)

San Diego VMC

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 12 weeks

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.

Time frame: Baseline to 12 weeks

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.

Time frame: Baseline (Day -4) to first dose (Day 1)

Secondary Outcomes

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.

Time frame: Baseline to 12 weeks

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.

Time frame: Baseline to 12 weeks

Data from ClinicalTrials.gov

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