Diabetes Mellitus
Conditions
Keywords
Diabetes Kidney transplantation, New onset diabetes mellitus after transplantation
Brief summary
The purpose of this study is to determine whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed New Onset Diabetes after Transplantation (NODAT).
Detailed description
Development of new onset diabetes mellitus after transplantation (NODAT) also called post-transplant diabetes mellitus (PTDM) increases the risk of cardiovascular disease and poor short term clinical outcomes. There is currently no doubt about the fact that NODAT is a condition that needs medical attention and treatment. Although most centers follow treatment regimens for DM type II prospective data about their effectiveness in NODAT are lacking. Little information exists in kidney transplantation regarding conventional glucose-lowering therapies, either oral hypoglycemic agents or traditional insulin regimens. The Aim of this study was to evaluate whether a monotherapy with Vildagliptin improve glycemic control and to assess the safety in kidney transplanted patients with newly diagnosed NODAT.
Interventions
DRUGVildagliptin
Patients receive once daily 50 mg Vildagliptin
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose): glucose ≥ 200mg/dl * renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of triple therapy with tacrolimus or cyclosporine A, mycophenolate mofetil or azathioprine, and prednisone. * stable graft function for more than 6 months post transplant. * informed consent of the patient
Exclusion criteria
* patients with prior history of type 1 or type 2 diabetes * body mass index (BMI) \> 40 * pregnancy * severe renal impairment (GFR \< 30 mL/min./1.73 m2) * severe liver impairment * severe blood glucose elevation with the need for therapy with insulin or HbA1c \>8.5%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start compared to placebo. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess differences in the change in HbA1c and fasting plasma glucose after 3 months after treatment start and to assess the safety and efficacy of Vildagliptin in renal transplanted patients. | 3 months |
Countries
Austria
Outcome results
None listed