Randomized Trial Comparing Colesevelam vs. Ezetimibe

• Status: Completed
• Trial end date: 2017-05-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Colesevelam Hydrochloride; Ezetimibe

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