Randomized Trial Comparing Colesevelam vs. Ezetimibe

LMC Diabetes & Endocrinology Ltd.200 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Type 2 Diabetes Mellitus

Interventions

ColesevelamDRUG

Colesevelam 3.75 g daily for 24 weeks

EzetimibeDRUG

Ezetimibe 10 mg daily for 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

LMC Calgary

Calgary, Alberta, Canada

LMC Barrie

Barrie, Ontario, Canada

LMC Brampton

Brampton, Ontario, Canada

LMC Etobicoke

Etobicoke, Ontario, Canada

Outcomes

Primary Outcomes

Proportion of subjects who achieve target HbA1c and LDL cholesterol

target HbA1c: ≤ 7.0%; target LDL cholesterol: ≤ 2.0 mmol/L

Time frame: 24 weeks

Secondary Outcomes

Proportion of subjects who achieve the primary outcome measure in the sub-group of subjects on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy

Time frame: 24 weeks

Absolute change in LDL cholesterol

Time frame: 24 weeks

Absolute change in non-high-density lipoprotein (non-HDL) cholesterol

Time frame: 24 weeks

Absolute change in fasting plasma glucose (FPG)

Time frame: 24 weeks

Absolute change in HbA1c

Time frame: 24 weeks

Absolute change in LDL cholesterol in sub-group of subjects on SGLT2i therapy

Time frame: 24 weeks

Absolute change in non-HDL cholesterol in sub-group of subjects on SGLT2i therapy

Time frame: 24 weeks

Absolute change in FPG in sub-group of subjects on SGLT2i therapy

Time frame: 12 weeks and 24 weeks

Absolute change in HbA1c in sub-group of subjects on SGLT2i therapy

Time frame: 12 weeks and 24 weeks

Proportion of subjects achieving a composite target of glycemic control, LDL cholesterol control and blood pressure control

Data from ClinicalTrials.gov

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