NCT00980356

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 (NODAT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Sep 2009

Typical duration for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 5, 2013

Status Verified

August 1, 2012

Enrollment Period

2.9 years

First QC Date

September 18, 2009

Last Update Submit

April 4, 2013

Conditions

Diabetes Mellitus

Keywords

Diabetes Kidney transplantationNew onset diabetes mellitus after transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Vildagliptin, 50 mg, peroral

ACTIVE COMPARATOR
Drug: Vildagliptin

Placebo pill

PLACEBO COMPARATOR

Interventions

VildagliptinDRUG

Patients receive once daily 50 mg Vildagliptin

Vildagliptin, 50 mg, peroral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (3)

  • Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

    PMID: 32803882DERIVED

  • Haidinger M, Werzowa J, Hecking M, Antlanger M, Stemer G, Pleiner J, Kopecky C, Kovarik JJ, Doller D, Pacini G, Saemann 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.

    PMID: 24279801DERIVED

  • Haidinger M, Werzowa J, Voigt HC, Pleiner J, Stemer G, Hecking M, Doller D, Horl WH, Weichhart T, Saemann 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.

    PMID: 20925938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marcus D Säemann, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Marcus Säemann

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

April 5, 2013

Record last verified: 2012-08

Locations

AU(1)