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A Study of Vildagliptin to Prevent Diabetes in Kidney Transplant Recipients During Early Post-Transplant Period

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

This study focuses on preventing new-onset diabetes in patients who have received a kidney transplant. After organ transplantation, some patients may develop diabetes as a complication of their treatment. The medication being tested is vildagliptin (also known as LAF237), which is given as tablets in the early period after transplantation.

The purpose of this research is to determine if short-term treatment with vildagliptin can prevent the development of diabetes in the first year after kidney transplantation. The medication is taken by mouth, with patients receiving up to 100 mg daily for a period of 8 weeks. During the study, patients will receive standard medications that help prevent rejection of the transplanted kidney, including tacrolimus, mycophenolic acid, and steroids.

Throughout the study, patients will have their blood sugar levels monitored regularly. Other aspects of health will also be checked, including kidney function, blood composition, and overall well-being. The study will track how many patients develop diabetes within one year after their transplant. Diabetes will be identified through blood sugar measurements or the need for diabetes medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    After receiving a kidney transplant, you will begin taking Galvus 50 mg tablets (vildagliptin) orally

    You will also receive standard medications including tacrolimus, mycophenolic acid, and steroids

    The steroid treatment may be discontinued around 3 months after transplantation

  2. Step 2

    3-month check-up

    Your doctor will perform laboratory tests to check:

    - Blood sugar levels

    - Glycated hemoglobin (HbA1c) - a measure of blood sugar control

    - Kidney function (creatinine levels)

    - Liver and pancreas function

    - Complete blood count

    You will complete a quality of life questionnaire

  3. Step 3

    6-month check-up

    Repeat of laboratory tests from the 3-month check-up

    Assessment for any signs of transplant rejection or infection

    Completion of quality of life questionnaire

  4. Step 4

    12-month final evaluation

    Final set of laboratory tests

    Assessment of diabetes status through:

    - Checking if you require diabetes medication

    - Measuring fasting blood sugar

    - Performing an oral glucose tolerance test (OGTT) - a test that measures how your body processes sugar

    Final quality of life questionnaire completion

    This marks the end of the study period

Who can join the trial?

10 criteria

  • Must be receiving a first kidney transplant
  • Must have at least 2 of these 3 risk factors for developing diabetes after transplant:
    • Age over 50 years
    • Body Mass Index (BMI) above 30 (indicates obesity)
    • Having close family members with type 2 diabetes
    • Must be able to take specific medications that suppress the immune system (immunosuppressive therapy), including:
      • Tacrolimus
      • Mycophenolic acid
      • Steroids
      • Must be able to stop taking steroids within 3 months after transplant
      • Can be either male or female
      • Must be an adult (18 years or older)

Who cannot join the trial?

15 criteria

  • History of diabetes mellitus (any condition causing high blood sugar levels) before transplantation
  • Previous organ transplantation other than current kidney transplant
  • Known allergy or sensitivity to vildagliptin (the study medication) or similar drugs
  • Severe kidney dysfunction after transplantation
  • Active or chronic infections that could affect recovery
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the last 30 days
  • Significant liver problems or abnormal liver function tests
  • Unstable heart conditions
  • Inability to follow study procedures or attend follow-up visits
  • Use of medications that could interact with the study drug
  • Major surgery planned during the study period (except for the transplant procedure)
  • Severe obesity or malnutrition that could affect study results
  • Immunosuppressive therapy (medications that lower immune system function) different from standard transplant protocol
  • Mental conditions that could interfere with providing informed consent
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Investigated drugs

Vildagliptin is a medication that helps control blood sugar levels. It belongs to a class of drugs called DPP-4 inhibitors. In transplant patients, this medication is being studied to prevent the development of diabetes after kidney transplantation. It works by helping the body produce more insulin when blood sugar is high and reducing the amount of sugar made by the liver.

What is already known about the treatment

Vildagliptin - An oral anti-diabetic medication belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class, which is administered in tablet form. The drug works by blocking the DPP-4 enzyme, leading to increased levels of incretin hormones that help regulate blood glucose levels by stimulating insulin production and reducing glucagon secretion. Vildagliptin is currently being studied in clinical trials for the prevention of new-onset diabetes in kidney transplant recipients during the early post-transplant period, representing a novel approach to managing transplant-related metabolic complications. The medication has already established its effectiveness in treating type 2 diabetes in the general population and shows promising potential in transplant medicine.

Investigated diseases

  • Post-transplant Diabetes Mellitus

    A metabolic disorder that develops in some patients after organ transplantation, specifically after kidney transplant in this context. This condition causes high blood sugar levels due to the body's inability to properly regulate glucose. The condition typically develops within the first year after transplantation. It shares similar characteristics with type 2 diabetes, including elevated fasting glucose levels and abnormal glucose tolerance. The condition can be influenced by immunosuppressive medications used after transplantation.

  • Chronic Kidney Disease

    A condition where kidneys gradually lose their ability to filter waste and excess fluid from the blood. The disease progresses through several stages, from mild kidney damage to complete kidney failure. The condition often develops slowly over many years. When kidneys fail completely, patients require either dialysis or kidney transplantation to survive.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516272-14-00Protocol codeN/2015/70Estimated enrolment186 patientsSponsorCentre Hospitalier Regional Universitaire

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