Vildagliptin in New Onset Diabetes After Transplantation

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Vildagliptin

Criteria

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%