Vildagliptin in New Onset Diabetes After Transplantation (ViNODAT). A double-blind, randomized, placebo-controlled trial
- Conditions
- new onset diabetes mellitus after transplantation
- Registration Number
- EUCTR2009-014405-14-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik Innere Medizin III, Abt.für Nephrologie u.Dialyse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-Newly diagnosed NODAT as defined by a pathologic OGTT (2h, 75mg glucose): glucose = 200mg/dl
-Age > 18 years
-Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression of our center, consisting of tacrolimus or cyclosporine A, mycophenolate mofetil, and prednisone triple therapy without any induction
-Stable graft function for more than 6 months post transplant
-Informed consent of the patient and willingness/ability to follow the instructions of the study team
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Patients with prior history of type 1 or type 2 diabetes
-BMI > 40
-Pregnancy (ß-HCG in blood will be measured in all female study participants before enrollment)
-severe renal impairment (GFR < 30 ML/min./1.73 m2)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method