GLP-1 receptor agonist in people on maintenance dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a parallel-group pilot randomized controlled trial assessing safety, tolerability, adherence, and feasibility of a GLP-1 receptor agonist (semaglutide) added to usual care in adults on maintenance dialysis with type 2 diabetes. The study plans to enroll about 100 participants across Canadian and potential international sites, randomizing them 1:1 to semaglutide or usual care for 26 weeks. Primary goals focus on safety and feasibility metrics, including recruitment rate, adherence, and complete follow-up; secondary outcomes cover adverse events, cardiovascular events, weight, glycemic control, insulin use, blood pressure, lipid levels, CKD-related bone-mineral markers, and quality of life. The overarching aim is to determine whether a larger cardiovascular outcomes trial in this population is feasible.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18
2. Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
3. confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
4. Ability to provided informed consent or through their substitute decision maker

Exclusion Criteria:

1. Type 1 DM
2. Use of a GLP-1-RA within 30 days prior to screening
3. Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)
4. Confirmed pregnancy, women of childbearing potential
5. Known hypersensitivity to GLP-1-RA
6. Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
7. Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA

Where it's running

• Unity Health Toronto
  Toronto, Ontario, Canada Recruiting
• Unity Health Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Ron Wald, MD — Unity Health Toronto
• Study coordinator: Ron Wald, MD
• Email: ron.wald@unityhealth.to
• Phone: (416) 867-3703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.