Randomized Trial Comparing Colesevelam vs. Ezetimibe (GOAL-RCT)

LMC Diabetes & Endocrinology Ltd.

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Colesevelam; Drug: Ezetimibe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02682680

GOAL RCT

Details and patient eligibility

About

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).

Full 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

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 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Colesevelam

Experimental group

Description:

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

Treatment:

Drug: Colesevelam

Ezetimibe

Active Comparator group

Description:

Ezetimibe 10 mg once daily for 24 weeks

Treatment:

Drug: Ezetimibe