Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

What Was Tested

This registered phase 4 trial tested Insulin Detemir.

In this study the researchers will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (active comparator).

The registry classes the interventions as drug.

More on the Plan

High sugar (glucose) is common after surgery, even in patients who do not have diabetes.

Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: total parenteral nutrition (tpn) or tube feeds; surgical procedures in the next 48 hours for whom intravenous (iv) insulin will be expected; expected length of stay less than 48 hours following cessation of the insulin drip.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

The Insulin Detemir group and the comparison group ran side by side rather than switching.

In this single-blind Insulin Detemir study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2008-07 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Patients With Morning (AM) Glucose Between [amount hidden]/dl on Day 2 and 3.

It also tracked 2 secondary outcomes, for example Reversion to Intravenous Insulin for Failure of Glycemic Control.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 82 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page, all human trials.