CompletedPhase 3

Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients

263 participantsStarted 2012-11-21

Plain-language summary

This study aims to assess the effects of early basal insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.The ITP NODAT study should be seen in connection with the Vienna SAPT-NODAT study (clinicaltrials.gov record number: NCT01680185), as for the final analysis, the data yielded from the three arms in those two studies will be used for an pooled analysis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
✓. Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose \< 126 mg/dl).
✓. Receiving standard triple immunosuppressive medications that include tacrolimus (once-daily in Europe, twice-daily in the U.S.), mycophenolate mofetil or mycophenolic sodium and steroids.
✓. Capable of understanding the study and willing to give informed written consent for study participation.

Exclusion criteria

✕. Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart.
✕. Patients receiving an organ transplant other than kidney.
✕. Patients receiving an unlicensed drug or therapy within one month prior to study entry.
✕. Patients with history of hypersensitivity to injectable insulin.
✕. Patients with documented HIV infection.

What they're measuring

incidence of NODAT

Timeframe: month 12 after kidney transplantation

Trial details

NCT IDNCT03507829

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-22

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