Can a popular diabetes drug help liver transplant patients control blood sugar?
NCT ID NCT05195944
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two diabetes medications, semaglutide and sitagliptin, in 58 adults who have had a liver transplant and have poorly controlled diabetes. The goal is to see which drug better lowers blood sugar and body weight. Participants will take the study drug daily for the trial duration, and all will continue standard post-transplant medications for life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, age ≥18 years at the time of signing informed consent. * Willing and able to provide informed consent. * Recipient of liver graft (Liver/Kidney recipients and retransplants allowed) * Time from transplant surgery ≥ 3 months at time of screening visit with no evidence of active rejection. Liver enzymes must be stable with elevations no greater than 2xULN. However, if patients have elevated liver enzymes beyond 2xULN due to NASH, as confirmed on liver biopsy, they may be included. * Patient diagnosed with type 2 diabetes or post-transplant diabetes * Patients transplanted for hepatocellular carcinoma may be included provide their latest surveillance imaging is negative for recurrence * The use of any immunosuppression regimen (calcineurin inhibitors, mycophenolate mofetil, maintenance prednisone or sirolimus) is acceptable * HbA1c 6.5-10.5% (53-91 mmol/mol) (both inclusive, not under optimal glycemic control). For purposes of clarification, patients on stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening, may be included (maximum 20% change in total daily dose within the 90 days is acceptable): * Basal insulin alone * Basal and bolus insulin in any combination * Premixed insulin including combinations of soluble insulin Concomitant treatment with stable daily dose of metformin and/or an SGLT2 inhibitor ≥ 90 days prior to the day of screening is allowed. Being on insulin, metformin, and/or an SGLT-2 inhibitor is optional. Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products. * Previous participation in this trial. * Active graft dysfunction that requires investigation (at screening). * Currently receiving steroids (prednisone) for treatment of acute cellular rejection. * Patients transplanted for multisystem genetic disorders such as amyloidosis or cystic fibrosis. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly-effective contraceptive methods (). * Receipt of any investigational medicinal product within 90 days before screening. * Any disorder or medical condition which, in the investigator's opinion, might jeopardize patient's safety or compliance with the protocol. * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). * History of pancreatitis (acute or chronic). * History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). * Any of the following: myocardial infarction (MI), stroke or hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening and randomization. * Classified as being in New York Heart Association (NYHA) Class IV. * Planned coronary, carotid or peripheral artery revascularization known on the day of screening. * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of ≤ 14 days. * Known history of proliferative retinopathy or maculopathy requiring acute treatment, unless stable * History or presence of actively treated malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, hepatocellular carcinoma, and carcinoma in situ.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
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