NCT01239004

Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study to Assess the LDL Cholesterol Lowering and Anti-Hyperglycemic Efficacy of Welchol® (Colesevelam) in Subjects With Impaired Fasting Glucose Who Are Taking Niaspan® (Niacin) for Dyslipidemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Radiant Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in dyslipidemic subjects with impaired fasting glucose.

Conditions

• Dyslipidemia
• Hyperlipidemia
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Placebo	6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
DRUG	Colesevelam	6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-11-11
• Last updated: 2012-01-06

Locations

4 sites across 1 country: United States