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

Tracking Information
First Received Date ^ICMJE	September 2, 2005
Last Updated Date	April 10, 2008
Start Date ^ICMJE	May 2005
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2008)	- 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 ]
Original Primary Outcome Measures ^ICMJE (submitted: September 2, 2005)	- To evaluate the effect of WelChol® on hepatic insulin sensitivity - To evaluate the acute effect of WelChol®, single or multi dose, on oral glucose absorption
Change History	Complete list of historical versions of study NCT00147745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 12, 2008)	- 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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 2, 2005)	- To evaluate the acute effect of WelChol®, single or multi dose, on oral glucose absorption - To evaluate the effect of WelChol® on hemoglobin A1c

Descriptive Information
Brief Title ^ICMJE	Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Official Title ^ICMJE	Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Pharmacodynamics Study
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Colesevelam Drug: Colesevelam matching placebo Drug: Insulin glargine (Lantus)
Study Arms / Comparison Groups	Experimental: colesevelam 3.8g administered daily for 12 weeks Placebo Comparator: Colesevelam matching placebo for 12 weeks Active Comparator: open-label Insulin Glargine for 12 weeks
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	45
Completion Date	January 2008
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00147745
Responsible Party	Michael Jones, Ph.D. Senior Director, Daiichi Sankyo Inc
Study ID Numbers ^ICMJE	WEL-201
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Daiichi Sankyo Inc.
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP