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Randomized Trial Comparing Colesevelam vs. Ezetimibe

NCT02682680 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-11-26

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Colesevelam

Colesevelam 3.75 g daily for 24 weeks

DRUG

Ezetimibe

Ezetimibe 10 mg daily for 24 weeks

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • LMC Diabetes & Endocrinology Ltd.

    lead OTHER

Principal Investigators

  • Harpreet Bajaj, MD · LMC Diabetes & Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682680 on ClinicalTrials.gov