WelChol® With Metformin in Treating Patients With Type 2 Diabetes

Phase 3 Completed 300 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 metformin alone or in combination with other anti-diabetic drugs.

Timeline

Start: 2004-06
Primary completion: 2006-07
Completion: 2006-07

Outcome

Met primary endpoint

paper Colesevelam lowered the mean HbA(1c) level compared with placebo at week 26 (-0.54%; P < .001). PMID 18852398 ↗

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. doi: 10.1001/archinte.168.18.1975.

Drugs

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