Colesevelam, Lipids And Sugars, South Asian Canadian Trial

Study Overview
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Brief Summary
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To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains above target despite optimal statin use.

Detailed Description
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This is a prospective, non-controlled, open label, multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk. 15-20 clinical sites from Ontario, Quebec, Manitoba and British Columbia will be selected from CCRN's network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable CAD with metabolic syndrome who are on maximally tolerated statin therapy, with LDL >2.0 mmol/L or non-HDL > 2.6 mmol/L. Following informed consent, patients will be screened at baseline for HbA1c, fasting blood glucose, lipid profile, renal function and liver enzymes. Baseline demographics, CAD and diabetes documentation and concurrent drug therapy will be collected. 250 eligible patients will receive a physician prescription of colesevelam (Lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks. Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial. Patients will be contacted at 2 and 12 weeks (visit 3 and 4) via a phone call to assess adherence to the prescribed therapy, review other concurrent medications and assess for any adverse events. The week 24 visit (study visit 5) will include collection of fasting blood work as per screening visit, review of concurrent drug therapy and a final assessment for any adverse events.

Official Title
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24 Week Open Label, Single Arm Study of Colesevelam in High Risk South Asians With Suboptimal LDL-c Levels Despite Maximally Tolerated Statin Therapy

Conditions
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Dyslipidemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan) Either Diabetes, or Coronary artery disease with metabolic syndrome Currently receiving maximally tolerated dose of statin therapy (at least Atorvastatin 20 mg or Rosuvastatin 10 mg) LDL >2.0 mmol/L or non-HDL >2.6 mmol/L Patient is willing to provide written consent Age ≥ 18 years Exclusion Criteria: Receiving lipid-lowering agents, other than statins or ezetimibe Any changes made to current lipid lowering therapy in the last 12 weeks Uncontrolled diabetes (HbA1c >0.10) TG > 5.0 mmol/L Significant hepatic or renal disease (ALT > 2x ULN or eGFR < 30 mL/min/1.73 m²) Ongoing participation in any randomized clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % difference in LDL between baseline and end of study |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % change in HbA1c levels between baseline and end of study |  | 6 months | 
| The absolute change in LDL and non-HDL levels between baseline and end of study |  | 6 months | 
| The safety and tolerability of colesevelam will be determined by the patient reported side/adverse effects and/or hospitalization related to Colesevelam. The side effects will be captured at Visit 3, 4 and 5. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDL cholesterol, A1c, High risk South Asians, Colesevelam