Vildagliptin in New Onset Diabetes After Transplantation (VINODAT)

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT00980356

EK645/2009

EudraCT: 2009-14405-14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups, including a placebo group

Vildagliptin, 50 mg, peroral

Active Comparator group

Treatment:

Drug: Vildagliptin

Placebo pill

Placebo Comparator group