Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Lispro.

During the study period blood glucose concentration, in whole blood, was measured every 30 minutes.

It had two arms (groups): Regular-insulin, (experimental) and Lispro insulin (experimental).

Patients randomly assigned in a crossover way to one of the 2 treatments.

The registry classes the interventions as drug.

More on the Plan

Exclusion criteria: moribund patients and patients enrolled on other studies were excluded.

A randomized crossover design is used.

Because of the crossover design of the study, the same patient is treated with both lispro insulin or regular insulin infusion allowing an interval of at least 6 hours between the 2 treatments.

The primary outcome measure was the extent of "residual effect" after that insulin (Hlog or Hlin) infusion has been discontinued.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: insulin dependent diabetes.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

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 2013-03 with completion listed for 2014-03.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Extent of insulin residual effect in critical care patients.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 28 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.