WelChol® and Insulin in Treating Patients With Type 2 Diabetes

Phase 3 Completed 260 enrolled Daiichi Sankyo

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start: 2004-06
Primary completion: 2005-12
Completion: 2005-12

Outcome

Met primary endpoint

paper treatment difference, -0.50% [0.09%]; 95% confidence interval, -0.68% to -0.32%; P < .001 PMID 18663165 ↗

paper the mean (SE) change in glycated hemoglobin level from baseline to week 16 was -0.41% (0.07%) for the colesevelam-treated group and 0.09% (0.07%) PMID 18663165 ↗

release “WelChol, when added to insulin, demonstrated a mean A1C reduction of 0.5% compared to placebo (-0.41% vs. +0.09%,p < 0.007).” daiichisankyo.com ↗

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. doi: 10.1001/archinte.168.14.1531.

Drugs

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