drugset / Trial / NCT00789750

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

NCT00789750

Phase 3 Completed 562 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-04
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 3.8 g
Background Pioglitazone Small molecule 30 mg
Background Pioglitazone Small molecule 45 mg