Vildagliptin in New Onset Diabetes After Transplantation (VINODAT)

April 4, 2013 updated by: Marcus Saemann, Medical University of Vienna

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo pill
Active Comparator: Vildagliptin, 50 mg, peroral
Drug: Vildagliptin
Patients receive once daily 50 mg Vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT: 2009-14405-14
  • EK645/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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