Vildagliptin in New Onset Diabetes After Transplantation - Full Text View

Purpose

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).

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Vildagliptin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Vildagliptin in New Onset Diabetes After Transplantation - A Double-blind, Randomized, Placebo-controlled Trial

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Enrollment:	32
Study Start Date:	September 2009
Study Completion Date:	December 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vildagliptin, 50 mg, peroral	Drug: Vildagliptin Patients receive once daily 50 mg Vildagliptin
Placebo Comparator: Placebo pill

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980356

Locations


Austria
Medical University of Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators


Principal Investigator:	Marcus D Säemann, MD	Medical University of Vienna

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haidinger M, Werzowa J, Hecking M, Antlanger M, Stemer G, Pleiner J, Kopecky C, Kovarik JJ, Döller D, Pacini G, Säemann MD. Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation--a randomized, double-blind, placebo-controlled trial. Am J Transplant. 2014 Jan;14(1):115-23. doi: 10.1111/ajt.12518. Epub 2013 Nov 26.

Haidinger M, Werzowa J, Voigt HC, Pleiner J, Stemer G, Hecking M, Döller D, Hörl WH, Weichhart T, Säemann MD. A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation. Trials. 2010 Oct 6;11:91. doi: 10.1186/1745-6215-11-91.


Responsible Party:	Marcus Saemann, Prof. Dr. Marcus Säemann, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00980356 History of Changes
Other Study ID Numbers:	EudraCT: 2009-14405-14 EK645/2009
Study First Received:	September 18, 2009
Last Updated:	April 4, 2013
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:


Diabetes Kidney transplantation New onset diabetes mellitus after transplantation

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Dipeptidyl-Peptidase IV Inhibitors	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

Vildagliptin in New Onset Diabetes After Transplantation (VINODAT)