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

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00147745

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 II

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Insulin glargine Colesevelam GT31-104

U.S. FDA Resources

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 ]
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 ]
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 ]

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 ]
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 ]

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

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:	Michael Jones, Ph.D. Senior Director, 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:	December 15, 2009
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
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 February 13, 2012