Vildagliptin in New Onset Diabetes After Transplantation

Medical University of Vienna32 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

VildagliptinDRUG

Patients receive once daily 50 mg Vildagliptin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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