drugset / Trial / NCT02682680
Randomized Trial Comparing Colesevelam vs. Ezetimibe
Phase 4
Completed
200 enrolled
LMC Diabetes & Endocrinology Ltd.
Bausch Health Americas, Inc. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colesevelam | Other / unclassified | 3.75 g | Oral |
| Comparator | Ezetimibe | Unknown | 10 mg | — |