WelChol® With Metformin in Treating Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00147719

First received: September 2, 2005

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2005
Last Updated Date	January 16, 2012
Start Date ^ICMJE	June 2004
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2005)	To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00147719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2006)	To assess the fasting plasma glucose and fructosamine lowering effect; To assess the glycemic control response rate; To assess the improvement in insulin sensitivity; To assess the effect on high sensitivity C-reactive protein; To assess the improvement in lipids, and lipoproteins; To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
Original Secondary Outcome Measures ^ICMJE (submitted: September 2, 2005)	-To assess the fasting plasma glucose and fructosamine lowering effect -To assess the glycemic control response rate -To assess the improvement in insulin sensitivity -To assess the effect on high sensitivity C-reactive protein -To assess the improvement in lipids, and lipoproteins -To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	WelChol® With Metformin in Treating Patients With Type 2 Diabetes
Official Title ^ICMJE	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
Brief Summary	The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Colesevelam hydrochloride
Study Arm (s)	Not Provided
Publications *	Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	July 2006
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Hemoglobin (HbA1c) between 7.5% to 9.5% Prescribed an ADA accepted diet Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1 Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment History of pancreatitis Uncontrolled hypertension Recent severe cardiovascular disease Allergy or toxic response to colesevelam or any of its components Body mass index (BMI) >45 kg/m2
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, Mexico, Peru

Administrative Information
NCT Number ^ICMJE	NCT00147719
Other Study ID Numbers ^ICMJE	WEL-301
Has Data Monitoring Committee	Not Provided
Responsible Party	Daiichi Sankyo Inc.
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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