Could a daily pill replace insulin for kidney transplant patients?
NCT ID NCT05702931
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether oral semaglutide (Rybelsus) can safely control high blood sugar in people who recently had a kidney transplant. About 104 participants will receive either the drug or a placebo for 14 weeks, alongside standard care. The goal is to see if it works as well as insulin without harming the new kidney or causing dangerous low blood sugar.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide (Rybelsus) - a tablet that lowers blood sugar and helps with weight loss
- What this could lead to
- If it works, this could offer a safer, more convenient alternative to insulin for managing high blood sugar after kidney transplant, potentially reducing weight gain and hypoglycemia risk.
- What could go wrong
- This is a small, early-phase trial (104 people) testing a drug not yet proven safe in transplant recipients. There are concerns about kidney graft function and gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2027
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 to 80 years
- 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: 1. Written informed consent obtained before any trial-related procedures are performed 2. Male or female; age: 18-80 years 3. Diagnosis of post-transplant hyperglycaemia 10 to 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L or Pre-transplant type 2 diabetes: Receiving glucose-lowring treatment prior to kidney transplantation 4. An eGFR \> 15 ml/min/1.73 m2 10 to 40 days after renal transplantation 5. Subject must be willing and able to comply with trial protocol Exclusion Criteria: 1. Type 1 diabetes 2. Dialysis 3. High risk immunological transplantation (not including ABO-incompatible or re-transplantation) 4. Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone) 5. Chronic pancreatitis/previous acute pancreatitis 6. Known or suspected hypersensitivity to trial or related products 7. Use of DPP-4 inhibitors within five days prior to screening 8. Use of GLP-1RA within 10 days prior to screening 9. Malignancy (except basal cell carcinoma) 10. Inflammatory bowel disease 11. Previous bowel resection 12. Cardiac disease defined as decompensated heart failure (New York Heart Association class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months 13. Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the initial trial visit schedule and procedures. 14. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods 15. Impaired liver function (plasma ALAT \> two times upper reference levels) 16. Elevated amylase (plasma amylase \> two times upper reference levels) 17. Untreated proliferative diabetic retinopathy, untreated diabetic macular edema or active conditions of this type that are not under therapeutic control according 18. Any condition that clinically significantly impairs the observation of the fundus or anterior chamber
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Department og Nephrology and Endocrinology, Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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