Vildagliptin in New Onset Diabetes After Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vildagliptin, 50 mg, peroral

Group Type ACTIVE_COMPARATOR

Vildagliptin

Intervention Type DRUG

Patients receive once daily 50 mg Vildagliptin

Placebo pill

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Vildagliptin

Patients receive once daily 50 mg Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No