| Trial ID: | L2522 |
| Source ID: | NCT02682680
|
| Associated Drug: |
Colesevelam
|
| Title: |
Randomized Trial Comparing Colesevelam vs. Ezetimibe
|
| Acronym: |
GOAL-RCT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Colesevelam|DRUG: Ezetimibe
|
| Outcome Measures: |
Primary: Proportion of subjects who achieve target HbA1c and LDL cholesterol, target HbA1c: ≤ 7.0%; target LDL cholesterol: ≤ 2.0 mmol/L, 24 weeks | Secondary: Proportion of subjects who achieve the primary outcome measure in the sub-group of subjects on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy, 24 weeks|Absolute change in LDL cholesterol, 24 weeks|Absolute change in non-high-density lipoprotein (non-HDL) cholesterol, 24 weeks|Absolute change in fasting plasma glucose (FPG), 24 weeks|Absolute change in HbA1c, 24 weeks|Absolute change in LDL cholesterol in sub-group of subjects on SGLT2i therapy, 24 weeks|Absolute change in non-HDL cholesterol in sub-group of subjects on SGLT2i therapy, 24 weeks|Absolute change in FPG in sub-group of subjects on SGLT2i therapy, 12 weeks and 24 weeks|Absolute change in HbA1c in sub-group of subjects on SGLT2i therapy, 12 weeks and 24 weeks|Proportion of subjects achieving a composite target of glycemic control, LDL cholesterol control and blood pressure control, glycemic control: A1c ≤ 7.0%; LDL cholesterol control: ≤ 2.0 mmol/L; blood pressure control: ≤ 130/80 mm Hg, 24 weeks|Proportion of subjects achieving a composite target of glycemic control with no hypoglycemia and no weight gain, 24 weeks|Proportion of subjects with ≥ 0.3% reduction in HbA1c and ≥ 10% reduction in LDL cholesterol from baseline, 24 weeks|Proportion of subjects with ≥ 0.5% reduction in HbA1c and ≥ 15% reduction in LDL cholesterol, 24 weeks|Absolute change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline, 24 weeks|Absolute change in triglyceride levels from baseline, 24 weeks|Proportion of subjects achieving target HbA1c and LDL cholesterol in the sub-group of subjects on non-insulin therapies, 24 weeks|Absolute change in FPG in the sub-group of subjects on non-insulin therapies, 24 weeks|Absolute change in HbA1c in the sub-group of subjects on non-insulin therapies, 24 weeks|Absolute change in LDL cholesterol in the sub-group of subjects on non-insulin therapies, 24 weeks|Absolute change in non-HDL cholesterol in the sub-group of subjects on non-insulin therapies, 24 weeks|Rate of non-severe and severe hypoglycemia, Severe hypoglycemia is defined as hypoglycemia requiring third party intervention of another person to actively administer carbohydrate, glucagon or other resuscitative actions., 24 weeks|Absolute change in alanine aminotransferase (ALT), 24 weeks|Absolute change in creatine kinase (CK), 24 weeks | Other: Change in body weight, 24 weeks|Change in body mass index (BMI), 24 weeks|Change in waist circumference, 24 weeks|Effect of colesevelam versus ezetimibe on the increased LDL cholesterol levels typically observed with initiation of SGLT2i therapy, 24 weeks|Persistence of therapy of colesevelam versus ezetimibe, 24 weeks|Persistence of therapy of colesevelam versus ezetimibe in the sub-group of subjects on SGLT2i therapy, 24 weeks|Mean dose of colesevelam, 12 weeks and 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: LMC Diabetes & Endocrinology Ltd. | Collaborators: Bausch Health Americas, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-01-11
|
| Completion Date: |
2017-05-25
|
| Results First Posted: |
|
| Last Update Posted: |
2019-11-26
|
| Locations: |
LMC Calgary, Calgary, Alberta, Canada|LMC Barrie, Barrie, Ontario, Canada|LMC Brampton, Brampton, Ontario, L6S 0C9, Canada|LMC Etobicoke, Etobicoke, Ontario, Canada|LMC Markham, Markham, Ontario, Canada|LMC Oakville, Oakville, Ontario, Canada|LMC Thornhill, Thornhill, Ontario, Canada|Manna Toronto, Toronto, Ontario, M9W 4L6, Canada|LMC Bayview, Toronto, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02682680
|
