Disorder Related to Renal TransplantationPhase 3PRODIGNCT02849899
Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period
A Phase 3 study testing Vildagliptin in people with Disorder Related to Renal Transplantation and Diabetes, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorder Related to Renal Transplantation, Diabetes
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2018to 5 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Patients (18 year old or older)
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
- Patient receiving a first kidney transplant
- Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
- Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids
- Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant
Who cannot join
- Legal disability or limited legal capacity
- Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
- Patient without health insurance
- Pregnancy
- Patient in the period of exclusion of another study or under the "national register of volunteers."
- Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study
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- Active infection
- Infection with Hepatitis C virus
- A history of diabetes
- Multi-Organ Transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation.
There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.
Read more
No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on β cells and anti-inflammatory effect.
The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.
- Being tested
- Vildagliptin, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called Galvus
Galvus is prescribed as recommended by the marketing authorization. In adults, the recommended dose of Galvus is 100 mg per day (one tablet in the morning and another in the evening).
In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily (one tablet in the morning).
Patients with creatinine clearance greater than 50 ml/min the vildalgliptin dose will be 100 mg/day. For those whose clearance is less than 50 ml/min, the daily dose is 50 mg. The creatinine clearance will be measured each week.
The treatment duration will be 3 months, divided into 2 months of complete treatment and one month of cessation treatment with half dose of vildagliptin.
PlaceboDrug
Also called Excipient
The placebo is the same as Galvus (packaging, shape, color, registration) but will contain only excipient. The given dose will also be identical.
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Active comparator | Group 1 will be treated with Vildagliptin 50 or 100 mg/day for 2 months, then 25 or 50 mg/d for 1 month depending on their creatinine assay. Receives: Drug: Vildagliptin |
| Placebo | Placebo comparator | Group 2 will be treated with placebo according to the same dosage. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes event
The primary endpoint is the proportion of diabetic patients 1 year after transplantation.
Diabetic patients are defined as one of the following proposals:
- Patients receiving a diabetic treatment
- Patients have a fasting glucose above 7 mmol/l
- Patients with an abnormal oral glucose tolerance test (OGTT)
Measured: 1 year
Secondary outcomes (4)
Glycemic control
The criteria for secondary assessments are abnormal blood glucose measured by: the glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation.
Measured: 3, 6 and 12 months
Acute rejection, infections, graft and patient survival
The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation.
Measured: 3, 6 and 12 months
The health-related quality of life improvement
The health-related quality of life (ReTRANSQOL questionnaire), 3 months, 6 months and 12 months after transplantation.
Measured: 3, 6 and 12 months
The cost-effectiveness ratio
The cost-effectiveness of prevention of diabetes with vildagliptin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start26 Oct 2018
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours, University Hospital, Lille, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Amiens University Hospital, University Hospital, Brest, Rennes University Hospital, Tenon Hospital, Paris, Centre Hospitalier Universitaire de Nice, University Hospital, Strasbourg, France
- Responsible party
- Sponsor
- Investigators
- Didier Ducloux, Pr., Principal investigator, Besançon University Hospital, Nephrology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849899
- Sponsor's protocol ID
- N/2015/70
- Acronym
- PRODIG
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2016
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaiffe E, Crepin T, Bamoulid J, Courivaud C, Buchler M, Cassuto E, Albano L, Chemouny JM, Choukroun G, Hazzan M, Kessler L, Legendre C, Le Meur Y, Ouali N, Thierry A, Anota A, Nerich V, Limat S, Bonnetain F, Vernerey D, Ducloux D. PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study. Trials. 2019 Jun 21;20(1):375. doi: 10.1186/s13063-019-3392-6.
PubMed 31227028
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period
- ClinicalTrials.gov ID
- NCT02849899
- Acronym / sponsor ID
- PRODIG / N/2015/70
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University Hospital, Tours, University Hospital, Lille, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Amiens University Hospital, University Hospital, Brest, Rennes University Hospital, Tenon Hospital, Paris, Centre Hospitalier Universitaire de Nice, University Hospital, Strasbourg, France
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation.
There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.
No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on β cells and anti-inflammatory effect.
The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Active comparator | Drug: VildagliptinGroup 1 will be treated with Vildagliptin 50 or 100 mg/day for 2 months, then 25 or 50 mg/d for 1 month depending on their creatinine assay. |
| Placebo | Placebo comparator | Drug: PlaceboGroup 2 will be treated with placebo according to the same dosage. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major Patients (18 year old or older)
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
- Patient receiving a first kidney transplant
- Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
Key exclusion criteria (10 listed)
- Legal disability or limited legal capacity
- Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
- Patient without health insurance
- Pregnancy
- Patient in the period of exclusion of another study or under the "national register of volunteers."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VildagliptinAlso: GalvusGalvus is prescribed as recommended by the marketing authorization. In adults, the recommended dose of Galvus is 100 mg per day (one tablet in the morning and another in the evening). In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily (one tablet in the morning). Patients with creatinine clearance greater than 50 ml/min the vildalgliptin dose will be 100 mg/day. For those whose clearance is less than 50 ml/min, the daily dose is 50 mg. The creatinine clearance will be measured each week. The treatment duration will be 3 months, divided into 2 months of complete treatment and one month of cessation treatment with half dose of vildagliptin. | Drug | Vildagliptin |
| PlaceboAlso: ExcipientThe placebo is the same as Galvus (packaging, shape, color, registration) but will contain only excipient. The given dose will also be identical. | Drug | Placebo |
Primary outcome
Diabetes event
Time frame: 1 year
The primary endpoint is the proportion of diabetic patients 1 year after transplantation. Diabetic patients are defined as one of the following proposals: * Patients receiving a diabetic treatment * Patients have a fasting glucose above 7 mmol/l * Patients with an abnormal oral glucose tolerance test (OGTT)
4 secondary outcomes
Glycemic control
Time frame: 3, 6 and 12 months
Acute rejection, infections, graft and patient survival
Time frame: 3, 6 and 12 months
The health-related quality of life improvement
Time frame: 3, 6 and 12 months
The cost-effectiveness ratio
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 31227028Gaiffe E, Crepin T, Bamoulid J, Courivaud C, Buchler M, Cassuto E, Albano L, Chemouny JM, Choukroun G, Hazzan M, Kessler L, Legendre C, Le Meur Y, Ouali N, Thierry A, Anota A, Nerich V, Limat S, Bonnetain F, Vernerey D, Ducloux D. PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study. Trials. 2019 Jun 21;20(1):375. doi: 10.1186/s13063-019-3392-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Ducloux, Pr. principal investigator
Besançon University Hospital, Nephrology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vildagliptin in people with Disorder Related to Renal Transplantation and Diabetes, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes event (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.