NCT00361153

Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.

Detailed description

Single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. Two parallel treatment groups include double-blind colesevelam or placebo. A screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. To evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. To evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (OGTT) at pre randomization, one without colesevelam and one with colesevelam, and one OGTT at the end of the treatment period..

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Colesevelam hydrochloride	Welchol tablet 625mg
DRUG	placebo	placebo

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-10-01
• Completion: 2007-03-01
• First posted: 2006-08-07
• Last updated: 2008-06-25

Locations

1 site across 1 country: United States