Status:
COMPLETED
Vildagliptin in New Onset Diabetes After Transplantation
Lead Sponsor:
Medical University of Vienna
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
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 ...
Eligibility Criteria
Inclusion
- • 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
- 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%
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00980356
Start Date
September 1 2009
End Date
December 1 2012
Last Update
April 5 2013
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090