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:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

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

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

- To evaluate the effect of WelChol® on hepatic insulin sensitivity [ Time Frame: January 22, 2008 ] [ Designated as safety issue: No ]
- To evaluate the acute effect of WelChol®, single or multi [ Time Frame: January 22, 2008 ] [ Designated as safety issue: No ]
dose, on oral glucose absorption [ Time Frame: January 22, 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- To evaluate the acute effect of WelChol®, single or multi [ Time Frame: January 2008 ] [ Designated as safety issue: No ]
dose, on oral glucose absorption [ Time Frame: January 2008 ] [ Designated as safety issue: No ]
- To evaluate the effect of WelChol® on hemoglobin A1c [ Time Frame: January 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	May 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental colesevelam 3.8g administered daily for 12 weeks	Drug: Colesevelam Colesevelam 3.8g for 12 weeks
2: Placebo Comparator Colesevelam matching placebo for 12 weeks	Drug: Colesevelam matching placebo Colesevelam matching placebo for 12 weeks
3: Active Comparator 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 (BMI 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 LDL-C 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:	Daiichi Sankyo Inc ( Michael Jones, Ph.D. Senior Director )
Study ID Numbers:	WEL-201
Study First Received:	September 2, 2005
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00147745 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Mechanism of action insulin sensitivity

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Colesevelam
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases

Anticholesteremic Agents
Insulin
Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009