Colesevelam, Lipids And Sugars, South Asian Canadian Trial
NCT ID: NCT02504736
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2015-06-30
2018-02-28
Brief Summary
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Detailed Description
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1. 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.
2. Following informed consent, patients will be screened at baseline for HbA1c, fasting blood glucose, lipid profile, renal function and liver enzymes.
3. Baseline demographics, CAD and diabetes documentation and concurrent drug therapy will be collected.
4. 250 eligible patients will receive a physician prescription of colesevelam (Lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks.
5. Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial.
6. 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.
7. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Valeant Canada Limited
INDUSTRY
Canadian Collaborative Research Network
OTHER
Responsible Party
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Principal Investigators
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Milan K Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Hamilton, ON Canada; University of Toronto, Toronto, ON Canada
Narendra Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Georgia Regents University, Georgia, US
Locations
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Dr. Milan Gupta,MD
Brampton, Ontario, Canada
Countries
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References
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Corsini A, Windler E, Farnier M. Colesevelam hydrochloride: usefulness of a specifically engineered bile acid sequestrant for lowering LDL-cholesterol. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):1-9. doi: 10.1097/HJR.0b013e32831215db.
Aggarwal S, Loomba RS, Arora RR. Efficacy of colesevelam on lowering glycemia and lipids. J Cardiovasc Pharmacol. 2012 Feb;59(2):198-205. doi: 10.1097/FJC.0b013e31823a109f.
Goldberg RB. Improving glycemic and cholesterol control through an integrated approach incorporating colesevelam - a clinical perspective. Diabetes Metab Syndr Obes. 2009 May 5;2:11-21. doi: 10.2147/dmsott.s3866.
Brunetti L, DeSantis EH. Patient tolerance and acceptance of colesevelam hydrochloride: focus on type-2 diabetes mellitus. P T. 2015 Jan;40(1):62-7.
Jialal I, Abby SL, Misir S, Nagendran S. Concomitant reduction in low-density lipoprotein cholesterol and glycated hemoglobin with colesevelam hydrochloride in patients with type 2 diabetes: a pooled analysis. Metab Syndr Relat Disord. 2009 Jun;7(3):255-8. doi: 10.1089/met.2009.0007.
Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.
Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.
Other Identifiers
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CLASS ACT-24-FEB-2015
Identifier Type: -
Identifier Source: org_study_id
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