Vildagliptin in New Onset Diabetes After Transplantation

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Vildagliptin

• Registration Number: NCT00980356
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin, 50 mg, peroral	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria