| Trial ID: | L5442 |
| Source ID: | NCT02849899
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period
|
| Acronym: |
PRODIG
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Disorder Related to Renal Transplantation|Diabetes
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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), 1 year | Secondary: 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., 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., 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., 3, 6 and 12 months|The cost-effectiveness ratio, The cost-effectiveness of prevention of diabetes with vildagliptin, 1 year
|
| Sponsor/Collaborators: |
Sponsor: Centre Hospitalier Universitaire de Besancon | 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
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
186
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2018-10-26
|
| Completion Date: |
2024-12
|
| Results First Posted: |
|
| Last Update Posted: |
2022-08-02
|
| Locations: |
CHU de Besançon, Besançon, 25000, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02849899
|
