Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period (PRODIG)
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|ClinicalTrials.gov Identifier: NCT02849899|
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was: Not yet recruiting
First Posted : July 29, 2016
Last Update Posted : August 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Disorder Related to Renal Transplantation Diabetes||Drug: Vildagliptin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2020|
Active Comparator: Vildagliptin
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.
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.
Other Name: Galvus
Placebo Comparator: Placebo
Group 2 will be treated with placebo according to the same dosage.
The placebo is the same as Galvus (packaging, shape, color, registration) but will contain only excipient. The given dose will also be identical.
Other Name: Excipient
- 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)
- Glycemic control [ Time Frame: 3, 6 and 12 months ]The criteria for secondary assessments are abnormal blood glucose measured by: the glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation.
- Acute rejection, infections, graft and patient survival [ Time Frame: 3, 6 and 12 months ]The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation.
- The health-related quality of life improvement [ Time Frame: 3, 6 and 12 months ]The health-related quality of life (ReTRANSQOL questionnaire), 3 months, 6 months and 12 months after transplantation.
- The cost-effectiveness ratio [ Time Frame: 1 year ]The cost-effectiveness of prevention of diabetes with vildagliptin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849899
|Contact: Emilie Gaiffe, Dr.||0381218824 ext +email@example.com|
|Contact: Ingrid Tissot||0381218427 ext +firstname.lastname@example.org|
|Principal Investigator:||Didier Ducloux, Pr.||Besançon University Hospital, Nephrology department|