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Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period (PRODIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.
Drug: Vildagliptin

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.
Drug: Placebo
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. The cost-effectiveness ratio [ Time Frame: 1 year ]
    The cost-effectiveness of prevention of diabetes with vildagliptin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active infection
  • Infection with Hepatitis C virus
  • A history of diabetes
  • Multi-Organ Transplantation

Information from the National Library of Medicine

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


Contacts
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Contact: Emilie Gaiffe, Dr. 0381218824 ext +33 egaiffe@chu-besancon.fr
Contact: Ingrid Tissot 0381218427 ext +33 itissot@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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
Investigators
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Principal Investigator: Didier Ducloux, Pr. Besançon University Hospital, Nephrology department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02849899    
Other Study ID Numbers: N/2015/70
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action