Vildagliptin in New Onset Diabetes After Transplantation

Diabetes Mellitus Clinical Trial

— VINODAT  

Official title:

Vildagliptin in New Onset Diabetes After Transplantation - A Double-blind, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980356
• Other study ID #: EudraCT: 2009-14405-14
• Secondary ID: EK645/2009
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2009
• Last updated: April 4, 2013
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Patients receive once daily 50 mg Vildagliptin

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes