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

Tracking Information
First Received Date ^ICMJE	September 2, 2005
Last Updated Date	March 27, 2007
Start Date ^ICMJE	June 2004
Primary Completion Date
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 NCT00147758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2006)	To assess the fasting plasma glucose and fructosamine lowering efficacy; To assess glycemic control response rate; To assess the improvement in insulin sensitivity; To assess the effect on C reactive protein; To assess lipids and lipoproteins; To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy
Original Secondary Outcome Measures ^ICMJE (submitted: September 2, 2005)	-To assess the fasting plasma glucose and fructosamine lowering efficacy -To assess glycemic control response rate -To assess the improvement in insulin sensitivity -To assess the effect on C reactive protein -To assess lipids and lipoproteins -To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

Descriptive Information
Brief Title ^ICMJE	WelChol® and Sulfonylurea 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 Sulfonylurea Monotherapy or Sulfonylurea 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 sulfonylurea 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 *	Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. Epub 2008 May 5.
* 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	400
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days Hemoglobin A1c value 7.5% to 9.5%, inclusive C peptide > 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 < 60 mg/dL Serum TG > 500 mg/dL 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 ID ^ICMJE	NCT00147758
Responsible Party
Study ID Numbers ^ICMJE	WEL-303
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