WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Phase 3 Completed 400 enrolled Daiichi Sankyo

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-06
Primary completion: 2006-08
Completion: 2006-08

Outcome

Met primary endpoint

paper A1C from baseline to week 26 was -0.32% in the colesevelam group and +0.23% in the placebo group PMID 18458145 ↗

paper resulting in a treatment difference of -0.54% (P < 0.001). PMID 18458145 ↗

release “sulfonylurea-based therapy the addition of Welchol was shown to have a significant reductions in A1C (mean reduction of 0.54%; p<0.001)” daiichisankyo.com ↗

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. doi: 10.2337/dc08-0283. Epub 2008 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colesevelam	Other / unclassified	3.75 g	—