drugset / Trial / NCT02682680

Randomized Trial Comparing Colesevelam vs. Ezetimibe

NCT02682680

RandomizedParallel-groupOpen-labelTreatment

Summary

A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for glycated hemoglobin (HbA1c) (\> 7.0%) and low-density lipoprotein (LDL) cholesterol (\> 2.0 mmol/L).

Timeline

Start
2016-01-11
Primary completion
2017-05-25
Completion
2017-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 3.75 g Oral
Comparator Ezetimibe Unknown 10 mg