Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

Summary

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Timeline

Start

2005-06

Primary completion

2008-01

Completion

2008-01

Outcome

Missed primary endpoint

registry Colesevelam 3.8g vs Colesevelam Matching Placebo; p = 0.5499; Mean Difference (Final Values) 0.04 (95% CI -0.10 to 0.19); ANCOVA NCT00147745 ↗

registry Colesevelam 3.8g vs Colesevelam Matching Placebo; p = 0.2042; Mean Difference (Final Values) 0.08 (95% CI -0.05 to 0.22); ANCOVA NCT00147745 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colesevelam	Other / unclassified	3.8 g	—
Comparator	insulin glargine	Protein / enzyme biologic	—	—

Indications