PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period

Phase 3

Not yet recruiting

• Conditions: renal transplant
• Interventions: Drug: Placebo; Drug: Vildagliptin

• Registration Number: 2024-516272-14-00
• Lead Sponsor: Centre Hospitalier Regional Universitaire

Brief Summary

to demonstrate that a short term treatment of vildagliptin administered in the early post-transplant period prevents the occurrence of post-transplant diabetes one year after kidney transplantation.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-13
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

Hepatic insufficiency

Patient with Class IV NYHA Heart Failure

Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome

Active infection

Infection with Hepatitis C virus

Multi-Organ Transplantation

A history of diabetes / pancreatitis /angioedema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group 2 will be treated with placebo according to the same dosage.
Vildagliptin	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.

Primary Outcome Measures

Name	Time	Method
the proportion of diabetic patients 1 year after transplantation, 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)		the proportion of diabetic patients 1 year after transplantation, 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)

Secondary Outcome Measures

Name	Time	Method
The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation		The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation
The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,		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 (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,		The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,
The cost of the care and treatment up to one year after transplantation.		The cost of the care and treatment up to one year after transplantation.

Trial Locations

Locations (9)

Centre Hospitalier Universitaire De Lille; 🇫🇷 Lille Cedex, France

Centre Hospitalier Universitaire De Poitiers; 🇫🇷 Poitiers, France

Hopital Necker Enfants Malades; 🇫🇷 Paris, France

CHU Besancon; 🇫🇷 Besancon Cedex, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours, France

Hopital Tenon; 🇫🇷 Paris Cedex 20, France

Centre Hospitalier Regional Et Universitaire De Brest; 🇫🇷 Brest, France

Centre Hospitalier Universitaire Amiens Picardie; 🇫🇷 Amiens, France

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Centre Hospitalier Universitaire De Lille

🇫🇷Lille Cedex, France

Marc HAZZAN

Site contact

0320445962

mhazzan@gmail.com