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This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.
The proposed study is a parallel group, pilot randomized controlled trial. The trial will recruit 100 participants across Canadian hospitals and potentially others worldwide. We will recruit patients receiving maintenance dialysis for ≥ 90 days who have a background of type 2 diabetes mellitus. We will exclude patients with type 1 diabetes mellitus and recent recipients of a GLP-1-RA. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks. The key feasibility outcomes are: (1) successful recruitment of fully eligible patients (≥40%); (2) adherence to the study intervention (≥70% participants take at least 70% of prescribed study drug doses); and (3) completeness of follow-up (≥90% participants are successfully followed to 26 weeks). Secondary outcomes will include adverse events, major adverse cardiovascular events, changes in body weight, glycemic control, insulin dosage, blood pressure, lipid parameters, markers of CKD-related bone mineral disease, and quality of life.
As a pilot RCT, GUARD-1 will focus on the safety and tolerability of the GLP-1-RA semaglutide in the maintenance dialysis population. The key question of this trial is whether an RCT to evaluate the cardiovascular effects of GLP-1-RA in the maintenance dialysis population is feasible based on study recruitment, adherence, follow-up and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus | |
| Semaglutide | Experimental | Individuals randomized to this arm will take semaglutide once weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen | Drug | Individuals randomized to this arm will take semaglutide once weekly. For participants receiving in-centre hemodialysis, the intervention may be administered during the dialysis session by nursing personnel based on the patient's preference. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence of Study Intervention | This will be determined if ≥ 70% of enrolled number of eligible participants (who are randomized) are adherent to the study intervention over the 26-week follow-up period. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study Medication Discontinuation | The number of enrolled participants who permanently discontinue the study medication in the semaglutide arm from baseline to 6 months. | 26 weeks |
| Feasibility of Study Recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ron Wald, MD | Contact | (416) 867-3703 | ron.wald@unityhealth.to | |
| Kevin Yau, MD | Contact | Kevin.Yau@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Ron Wald, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unity Health Toronto | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D007676 | Kidney Failure, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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This will be determined if ≥ 40% of the number of fully eligible participants (potential participants who were screened and identified to meet inclusion/exclusion criteria) consent to participate in the trial.
| 26 weeks |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | We will measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] and identify safety events of special interest such as gastrointestinal symptoms, acute biliary disease, acute pancreatitis, interventions for diabetic retinopathy, heart failure exacerbations, malignant neoplasms, and the number of hypoglycemic events. | 26 weeks |
| Major Adverse Cardiovascular Events | This is a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, or a peripheral arterial event. | 26 weeks |
| Follow Up Percentage at 26 weeks | To determine if ≥ 90% of participants (who are enrolled) will be successfully followed to week 26 (end of study participation). | 26 weeks |
| Patient Reported Measures | The validated EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) score will be used to evaluate baseline-adjusted changes in quality of life and symptom burden. The EQ-5D-5L asks individuals to rate their overall health on a visual scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. | 26 weeks |
| Unity Health Toronto | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |