WelChol® and Insulin in Treating Patients With Type 2 Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	September 7, 2005
Last Updated Date	March 27, 2007
Start Date ^ICMJE	June 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 7, 2005)	- To assess the additional lowering of HbA1c achieved by addition of WelChol® to current antidiabetic therapy
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00151749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 26, 2006)	To assess: the effects on fasting plasma glucose and fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add- on therapy to patients receiving insulin alone or with other oral drugs
Original Secondary Outcome Measures ^ICMJE (submitted: September 7, 2005)	- To assess the effects on fasting plasma glucose and fructosamine - To assess glycemic control response rate - To assess effect on adiponectin - To assess the effect on c-peptide - To assess effect on c-reactive protein - To assess effects on lipids and lipoproteins - To assess the safety and tolerability of WelChol® as add- on therapy to patients receiving insulin alone or with other oral drugs

Descriptive Information
Brief Title ^ICMJE	WelChol® and Insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy 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 WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Colesevelam hydrochloride
Study Arms / Comparison Groups
Publications *	Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40.
* 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
Enrollment ^ICMJE	260
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Ages 18 - 75 years, inclusive Diagnosed with type 2 diabetes Stable insulin therapy for 6 weeks Stable dose of any other antidiabetic medications for 90 days Hemoglobin A1c value between 7.5% to 9.5% C peptide greater than 0.5 ng/mL Prescribed ADA diet Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of pancreatitis Uncontrolled hypertension Allergy or toxic response to colesevelam or any of its components Serum LDL-C less than 60 mg/dL Serum TG greater than 500 mg/dL Body mass index (BMI) greater than 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 ID ^ICMJE	NCT00151749
Responsible Party
Study ID Numbers ^ICMJE	WEL-302
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Daiichi Sankyo Inc.
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP