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

What Was Tested

The trial (phase 3) is built around Insulin Lispro and NPH Insulin (isophane).

It had three arms (groups): Basal insulin (active comparator), Standard of care (active comparator) and Sensor-augmented Insulin Pump (active comparator).

Patients assigned in this arm will receive standard of care following their kidney transplantation.

Continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation.

The registry classes the interventions as drug.

More on the Plan

Adult patients with absence of diabetes will be randomized prior to renal transplantation and stratified by deceased donor or living donor, if they are capable of understanding the study and are willing to give informed written consent for all three study arms.

The algorithm for insulin administration is designed to account for the prominent evening peak of hyperglycemia observed in their previous TIP-study.

All secondary endpoint comparisons relying on OGTTs will be made at 6, 12 and 24 months after kidney transplantation, respectively.

Who Took Part

263 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney. 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-11-21 with completion listed for 2018-05-22.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: incidence of NODAT (time frame: month 12 after kidney transplantation).

It also tracked 10 secondary outcomes, for example The incidence of NODAT at 24 months after kidney transplantation, Glycemia profile during the time of insulin therapy in arm A (intervention) comparing that of arm B (control), Incidence of impaired fasting glycemia and impaired glucose tolerance 6, 12 and 24 months after transplantation, Renal function at 6, 12 and 24 months after kidney transplantation, measured by serum creatinine and Patient and graft survival 6, 12 and 24 months after kidney transplantation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro and NPH Insulin (isophane) in 263 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page and the NPH Insulin (isophane) compound page, all human trials.