Randomized Trial Comparing Colesevelam vs. Ezetimibe

NCT ID: NCT02682680

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-11
• Study Completion Date: 2017-05-25

Brief 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).

Detailed Description

This study will enroll 200 adult patients with T2DM who are not at target for HbA1c and LDL cholesterol. Patients who are on baseline statin therapy will be randomly assigned in a 1:1 ratio to colesevelam 3.75 g daily for 24 weeks, or ezetimibe 10 mg daily for 24 weeks. If a patient has statin intolerance, they may be on a fibrate and/or niacin, or on no lipid lowering therapy. The primary efficacy objectives are

1. to demonstrate that colesevelam 3.75 g daily is non-inferior to ezetimibe 10 mg daily as add-on to statin therapy for patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24, and

2. to compare the proportion of patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24.

This study will also assess the primary composite outcome in a sub-group of patients on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colesevelam

Colesevelam 3.75 g daily (tablets or oral suspension) for 24 weeks

Group Type: EXPERIMENTAL

Colesevelam

Intervention Type: DRUG

Colesevelam 3.75 g daily for 24 weeks

Ezetimibe

Ezetimibe 10 mg once daily for 24 weeks

Group Type: ACTIVE_COMPARATOR

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg daily for 24 weeks

Interventions

Colesevelam

Colesevelam 3.75 g daily for 24 weeks

Intervention Type: DRUG

Ezetimibe

Ezetimibe 10 mg daily for 24 weeks

Intervention Type: DRUG

Other Intervention Names

Lodalis; Welchol; Ezetrol; Zetia

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of type 2 diabetes > 6 months

2. HbA1c level between 7.1 to 10.0% (inclusive) within three months of study enrollment

3. LDL cholesterol > 2.0 mmol/L within three months of study enrollment

4. Receiving a stable dose of statin for a minimum of three months, which the investigator does not plan to change over the 24-week trial period. If patient has documented statin intolerance, may be on a fibrate and/or niacin, or on no lipid lowering therapy

5. Stable diabetes medications for previous three months (apart from adjustment of insulin dose)

6. Informed consent

Exclusion Criteria

1. Use of a second lipid lowering therapy other than statin within three months of study enrolment, unless on a fibrate and/or niacin if patient has statin intolerance

2. Triglycerides ≥ 5.0 mmol/L or incalculable LDL cholesterol

3. Significant liver enzyme or CK elevation defined as CK or ALT ≥ 3x upper limit of normal (ULN)

5) Pregnant or breast feeding or planning to become pregnant or breast feed during the study 6) Chronic kidney disease (CKD) stage ≥4 or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m-squared 7) Severe gastroparesis or history of significant bowel resection 8) Current use of any Investigational Product

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

LMC Diabetes & Endocrinology Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harpreet Bajaj

Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harpreet Bajaj, MD

Role: PRINCIPAL_INVESTIGATOR

LMC Diabetes & Endocrinology

Locations

LMC Calgary

Calgary, Alberta, Canada

LMC Barrie

Barrie, Ontario, Canada

LMC Brampton

Brampton, Ontario, Canada

LMC Etobicoke

Etobicoke, Ontario, Canada

LMC Markham

Markham, Ontario, Canada

LMC Oakville

Oakville, Ontario, Canada

LMC Thornhill

Thornhill, Ontario, Canada

Manna Toronto

Toronto, Ontario, Canada

LMC Bayview

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GOAL RCT

Identifier Type: -

Identifier Source: org_study_id