No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Unity Health Toronto · Other
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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…
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
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