NCT00789750

Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 562 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Colesevelam	Colesevelam 625 mg tablets
DRUG	Placebo	Placebo tablets appearing to be colesevelam
DRUG	Pioglitazone	30 mg or 45 mg pioglitazone therapy

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-11-13
• Last updated: 2017-06-26
• Results posted: 2017-06-26

Locations

141 sites across 1 country: United States