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

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ClinicalTrials.gov Identifier: NCT02682680
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Dr. Harpreet Bajaj, LMC Diabetes & Endocrinology Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Colesevelam Drug: Ezetimibe Phase 4

Detailed 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

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Goal Achievement of A1c and LDL in a Randomized Trial Comparing Colesevelam vs. Ezetimibe as Add-on to Baseline Statin Therapy: The GOAL-RCT Trial
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017


Arm Intervention/treatment
Experimental: Colesevelam
Colesevelam 3.75 g daily (tablets or oral suspension) for 24 weeks
Drug: Colesevelam
Colesevelam 3.75 g daily for 24 weeks
Other Names:
  • Lodalis
  • Welchol

Active Comparator: Ezetimibe
Ezetimibe 10 mg once daily for 24 weeks
Drug: Ezetimibe
Ezetimibe 10 mg daily for 24 weeks
Other Names:
  • Ezetrol
  • Zetia




Primary Outcome Measures :
  1. Proportion of subjects who achieve target HbA1c and LDL cholesterol [ Time Frame: 24 weeks ]
    target HbA1c: ≤ 7.0%; target LDL cholesterol: ≤ 2.0 mmol/L


Secondary Outcome Measures :
  1. 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 ]
  2. Absolute change in LDL cholesterol [ Time Frame: 24 weeks ]
  3. Absolute change in non-high-density lipoprotein (non-HDL) cholesterol [ Time Frame: 24 weeks ]
  4. Absolute change in fasting plasma glucose (FPG) [ Time Frame: 24 weeks ]
  5. Absolute change in HbA1c [ Time Frame: 24 weeks ]
  6. Absolute change in LDL cholesterol in sub-group of subjects on SGLT2i therapy [ Time Frame: 24 weeks ]
  7. Absolute change in non-HDL cholesterol in sub-group of subjects on SGLT2i therapy [ Time Frame: 24 weeks ]
  8. Absolute change in FPG in sub-group of subjects on SGLT2i therapy [ Time Frame: 12 weeks and 24 weeks ]
  9. Absolute change in HbA1c in sub-group of subjects on SGLT2i therapy [ Time Frame: 12 weeks and 24 weeks ]
  10. Proportion of subjects achieving a composite target of glycemic control, LDL cholesterol control and blood pressure control [ Time Frame: 24 weeks ]
    glycemic control: A1c ≤ 7.0%; LDL cholesterol control: ≤ 2.0 mmol/L; blood pressure control: ≤ 130/80 mm Hg

  11. Proportion of subjects achieving a composite target of glycemic control with no hypoglycemia and no weight gain [ Time Frame: 24 weeks ]
  12. Proportion of subjects with ≥ 0.3% reduction in HbA1c and ≥ 10% reduction in LDL cholesterol from baseline [ Time Frame: 24 weeks ]
  13. Proportion of subjects with ≥ 0.5% reduction in HbA1c and ≥ 15% reduction in LDL cholesterol [ Time Frame: 24 weeks ]
  14. Absolute change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline [ Time Frame: 24 weeks ]
  15. Absolute change in triglyceride levels from baseline [ Time Frame: 24 weeks ]
  16. Proportion of subjects achieving target HbA1c and LDL cholesterol in the sub-group of subjects on non-insulin therapies [ Time Frame: 24 weeks ]
  17. Absolute change in FPG in the sub-group of subjects on non-insulin therapies [ Time Frame: 24 weeks ]
  18. Absolute change in HbA1c in the sub-group of subjects on non-insulin therapies [ Time Frame: 24 weeks ]
  19. Absolute change in LDL cholesterol in the sub-group of subjects on non-insulin therapies [ Time Frame: 24 weeks ]
  20. Absolute change in non-HDL cholesterol in the sub-group of subjects on non-insulin therapies [ Time Frame: 24 weeks ]
  21. Rate of non-severe and severe hypoglycemia [ Time Frame: 24 weeks ]
    Severe hypoglycemia is defined as hypoglycemia requiring third party intervention of another person to actively administer carbohydrate, glucagon or other resuscitative actions.

  22. Absolute change in alanine aminotransferase (ALT) [ Time Frame: 24 weeks ]
  23. Absolute change in creatine kinase (CK) [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. Change in body weight [ Time Frame: 24 weeks ]
  2. Change in body mass index (BMI) [ Time Frame: 24 weeks ]
  3. Change in waist circumference [ Time Frame: 24 weeks ]
  4. Effect of colesevelam versus ezetimibe on the increased LDL cholesterol levels typically observed with initiation of SGLT2i therapy [ Time Frame: 24 weeks ]
  5. Persistence of therapy of colesevelam versus ezetimibe [ Time Frame: 24 weeks ]
  6. Persistence of therapy of colesevelam versus ezetimibe in the sub-group of subjects on SGLT2i therapy [ Time Frame: 24 weeks ]
  7. Mean dose of colesevelam [ Time Frame: 12 weeks and 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682680


Locations
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Canada, Alberta
LMC Calgary
Calgary, Alberta, Canada
Canada, Ontario
LMC Barrie
Barrie, Ontario, Canada
LMC Brampton
Brampton, Ontario, Canada, L6S 0C9
LMC Etobicoke
Etobicoke, Ontario, Canada
LMC Markham
Markham, Ontario, Canada
LMC Oakville
Oakville, Ontario, Canada
LMC Thornhill
Thornhill, Ontario, Canada
Manna Toronto
Toronto, Ontario, Canada, M9W 4L6
LMC Bayview
Toronto, Ontario, Canada
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.
Bausch Health Americas, Inc.
Investigators
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Principal Investigator: Harpreet Bajaj, MD LMC Diabetes & Endocrinology
Layout table for additonal information
Responsible Party: Dr. Harpreet Bajaj, Endocrinologist, LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT02682680    
Other Study ID Numbers: GOAL RCT
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Harpreet Bajaj, LMC Diabetes & Endocrinology Ltd.:
diabetes
hyperlipidaemia
colesevelam
ezetimibe
LDL cholesterol
glycated hemoglobin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ezetimibe
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents