Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro and NPH Insulin (isophane).

Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.

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

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.

NPH insulin titration regimen, as specified in the IPT-NODAT study.

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

The registry classes the interventions as drug and other.

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.

Prediabetes however is an independent predictor of all-cause mortality in patients after renal transplantation, and therefore not only a harbinger of overt diabetes mellitus but rather a high-risk condition per se.

Who Took Part

85 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, 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.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2012-08 with completion listed for 2018-05.

It ran at 1 site in Austria.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Glycosylated hemoglobin (HbA1c) (time frame: 3 months after transplantation).

It also tracked 7 secondary outcomes, for example Glycosylated hemoglobin (HbA1c), Oral glucose tolerance test (OGTT)-derived 2 hour-glucose, Fasting glucose, Beta cell function, Insulin sensitivity and Daily glucose measurements.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro and NPH Insulin (isophane) in 85 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.