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Semaglutide, Glucose and Glucagon for Prevention of Post‑transplantation Diabetes Mellitus in Kidney Transplant Recipients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on preventing a type of diabetes that can appear after a kidney transplantation. This condition, called Post-transplantation Diabetes Mellitus, can develop when the body’s ability to control blood sugar is affected by the transplant and the medicines used. The treatment being tested is a medication that imitates a natural hormone called GLP‑1; the drug’s active ingredient is semaglutide and it is given as a small injection under the skin. This type of drug is known as a GLP‑1RA.

The purpose of the study is to see whether a three‑month course of the medication can keep the diabetes from developing in the first six months after the transplant. Participants who have received a kidney transplant within the past six months will receive the study medication (or a placebo) for three months and will attend regular clinic visits where blood samples are taken. These samples are used to check blood‑sugar control with a test called HbA1c (which shows average sugar levels over several weeks) and to assess kidney function with eGFR (a number that tells how well the kidneys are filtering blood). Other routine checks include weight, blood pressure and simple questionnaires about health.

During the follow‑up period, researchers will also look at other health indicators such as urine protein, cholesterol levels and any signs of organ rejection. In one center, a detailed test called a hyperglycaemic clamp may be performed, using a hormone called glucagon to see how well the pancreas can produce insulin when blood sugar is high. Participants will complete quality‑of‑life surveys to report how they feel overall and whether they experience any stomach symptoms.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment and eligibility confirmation

    After you have received a kidney transplantation and are within six months post‑operation, you will be asked to join the study. your medical records will be reviewed to confirm that you meet the study criteria.

  2. Step 2

    Baseline assessments

    At the first study visit, you will undergo blood tests to measure kidney function (eGFR), blood sugar control (hbA1c), lipid levels, and other laboratory markers.

    Your body weight, blood pressure, and urine protein‑creatinine ratio will be recorded.

    You will complete two questionnaires: the sf‑36 to assess general quality of life and the gsrs to evaluate gastrointestinal symptoms.

    If you attend the rume clinic, a special test called a hyperglycaemic clamp with glucagon stimulation may be performed to assess beta‑cell function.

  3. Step 3

    Starting the study medication

    You will receive a pre‑filled pen containing semaglutide, a glucagon‑like peptide‑1 receptor agonist (glp‑1ra). the medication is injected under the skin (subcutaneous injection).

    The dosing schedule is weekly: the first four weeks you will use the 0.25 mg pen, weeks five to eight you will use the 0.5 mg pen, and weeks nine to twelve you will use the 1 mg pen. each dose is administered once a week for a total of three months.

  4. Step 4

    Self‑monitoring and safety measures

    You will be instructed to check your blood sugar levels regularly and to note any symptoms such as dizziness, sweating, or feeling unusually hungry.

    If a low blood sugar episode occurs, you may be given a glucagon injection (glucagon kit) or an intravenous glucose solution (20 % glucose) to raise your blood sugar quickly.

  5. Step 5

    Regular follow‑up visits during treatment

    You will return to the study clinic approximately every four weeks while you are taking the medication. during each visit, blood tests, weight, and blood pressure will be checked, and you will answer the same quality‑of‑life questionnaires.

    The study team will review your injection technique and any side effects you may have experienced.

  6. Step 6

    Completion of the three‑month medication period

    After twelve weeks of weekly injections, you will stop receiving the study medication.

    A final set of laboratory measurements and questionnaires will be performed at the end of the treatment phase.

  7. Step 7

    Post‑treatment follow‑up to six months post‑transplant

    You will continue to be monitored until six months after your kidney transplantation. during this period, additional blood tests, weight, blood pressure, and urine protein‑creatinine ratio will be collected.

    The primary goal is to determine whether you develop post‑transplantation diabetes mellitus within the first six months after transplant.

    Secondary information such as kidney function, lipid profile, any episodes of organ rejection, and quality‑of‑life scores will also be recorded.

Who can join the trial?

2 criteria

  • Be between 18 and 75 years old and have received a kidney transplant from a living or deceased donor.
  • Have an increased chance of developing post‑transplant diabetes mellitus (PTDM), which means you must meet at least one of these risk factors: age 49 years or older, history of gestational diabetes (diabetes that occurred during pregnancy), pre‑transplant HbA1c ≥ 37 mmol/mol (a blood test that shows average sugar levels over several weeks), pre‑transplant fasting glucose ≥ 5.6 mmol/L (blood sugar measured after not eating), BMI ≥ 27.5 kg/m² (body‑mass index, a measure of weight relative to height), waist circumference of 87.5 cm for men or 83.5 cm for women (measurement of abdominal size), or a first‑degree relative with type 2 diabetes (T2D) (a parent, sibling, or child who has diabetes).

Who cannot join the trial?

8 criteria

  • Having diabetes that already needs medicine, or having used a drug called a GLP‑1RA (a type of medicine that helps control blood sugar) or a similar GLP‑1/GIP co‑agonist within the past 6 months.
  • Having a body‑mass index (BMI) lower than 23 kg/m², which means being underweight according to the study’s criteria.
  • Having ongoing high blood sugar (persistent hyperglycemia) right after the kidney transplant that required medication to lower sugar before leaving the hospital.
  • Having any reason why you cannot take semaglutide (the specific study drug), as listed in its official safety information (EPARs).
  • Being currently pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Being at high risk for sarcopenia (loss of muscle mass), shown by a score of 4 or more on the SARC‑F questionnaire (a simple survey that checks muscle strength and function).
  • Having had pancreatitis (inflammation of the pancreas) that was caused by using a GLP‑1RA in the past.
  • Having had a condition called non‑arteritic ischemic optic neuropathy (NAION), which can cause loss of vision in one eye (unilateral blindness).
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Investigated drugs

  • Ozempic

    is a brand name for semaglutide, a medication that activates the GLP‑1 receptor. It is given as a subcutaneous injection using a pre‑filled pen. In this study the drug is being tested to see if taking it for three months can stop new‑onset diabetes after a kidney transplant. It helps the body use insulin better and reduces the amount of glucose made by the liver, which may keep blood sugar levels normal after the transplant.

  • Glucose 20% solution for infusion

    is a sterile liquid that contains a high concentration of glucose (sugar). It is delivered directly into the bloodstream through an IV line. In the trial it is used as a background therapy to supply energy and help keep blood sugar steady while participants recover from their transplant.

  • GlucaGen Hypokit

    contains glucagon, a hormone that quickly raises blood sugar. It comes as a powder that is mixed with a liquid and then given by intravenous injection. In the study it is available as a background medication to treat low blood sugar if it occurs, helping to keep participants safe during the trial.

What is already known about the treatment

  • Ozempic 1 mg solution for injection in pre-filled pen

    This medication is given as a subcutaneous injection using a ready‑to‑use pen. It is an approved drug that is widely used to treat type 2 diabetes and to help with weight loss. It works by mimicking the natural hormone GLP‑1, which boosts insulin release, reduces the amount of glucagon, and slows stomach emptying. It belongs to the class of GLP‑1 receptor agonists (incretin mimetics).

  • Ozempic 0.5 mg solution for injection in pre-filled pen

    This product is administered by a subcutaneous injection with a pre‑filled pen. It is an approved treatment for type 2 diabetes and for weight management in many countries. It activates the GLP‑1 receptor, increasing insulin, lowering glucagon, and slowing digestion to lower blood sugar. It is classified as a GLP‑1 receptor agonist.

  • Ozempic 0.25 mg solution for injection in pre-filled pen

    This drug is delivered by subcutaneous injection using a pre‑filled pen. It is a licensed medication for managing type 2 diabetes and assisting weight loss. It works by acting like the body’s GLP‑1 hormone, which raises insulin, lowers glucagon, and slows the stomach’s emptying rate. It falls under the GLP‑1 receptor agonist drug class.

  • Glucose 20 % solution for infusion

    This solution is given intravenously as an infusion into a vein. It is a standard, widely used medical product to provide quick energy and raise low blood sugar levels. It supplies glucose directly to the bloodstream, instantly increasing the body’s sugar supply. It is classified as a carbohydrate (glucose) solution for infusion.

  • GlucaGen Hypokit 1 mg powder and solvent for injection

    This medication is reconstituted and then given by injection, usually intravenously or intramuscularly. It is an approved emergency drug used to treat severe low blood sugar. It contains glucagon, a hormone that tells the liver to release stored glucose, quickly raising blood sugar. It belongs to the glucagon hormone class.

Investigated diseases

Post-transplantation diabetes mellitus - Post-transplantation diabetes mellitus is a condition in which high blood sugar develops after an organ transplant, most often a kidney transplant. It usually appears within the first few months after surgery as the body reacts to immunosuppressive medications that can reduce insulin secretion and increase insulin resistance. Early signs include elevated fasting glucose or abnormal glucose tolerance tests. If the abnormality persists, it progresses to chronic hyperglycemia that meets the criteria for diabetes. Ongoing high glucose can affect the transplanted kidney and other organs, making regular monitoring important.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525910-77-00Estimated enrolment100 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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