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

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

Outcome

Met primary endpoint

paper Colesevelam decreased HbA1c [least-squares mean treatment difference, - 3.5 mmol/mol (- 0.32%); p < 0.001] PMID 25054436 ↗

Publications

Rosenstock J, Truitt KE, Baz-Hecht M, Ford DM, Tao B, Chou HS. Efficacy and safety of colesevelam in combination with pioglitazone in patients with type 2 diabetes mellitus. Horm Metab Res. 2014 Dec;46(13):943-9. doi: 10.1055/s-0034-1383648. Epub 2014 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colesevelam	Other / unclassified	3.8 g	—
Background	Pioglitazone	Small molecule	30 mg	—
Background	Pioglitazone	Small molecule	45 mg	—