Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

This study will examine two questions: 1.

It had two arms (groups): aspart detemir (active comparator) and usual care (no intervention).

These subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 176 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.

Examples of who could join: Age 18-80 years. History of type 2 diabetes mellitus for at least 3 months. Prior therapy with dietary management, oral agents, or insulin. Non child-bearing potential or a negative urine pregnancy test.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation; patients with critical illness suspected to require intensive care unit admission or direct surgical intervention; history of current drug or alcohol abuse.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2008-05 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hospital Length of Stay (time frame: from hospital admission to hospital discharge).

It also tracked 4 secondary outcomes, for example Average Blood Glucose During the Hospital Admission, Frequency of Hypoglycemia and Frequency of Hypoglycemia During Emergency Room Therapy With Insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 176 people.

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

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