The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

It had two arms (groups): insulin glulisine (active comparator) and insulin aspart (active comparator).

The registry classes the interventions as drug.

More on the Plan

Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 4 years up to 11 years.

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

Examples of who could join: Ages 4-11 years;. Prepubertal (Tanner Stage I);. Diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;. At least six months from date of diagnosis of type 1 diabetes mellitus;. TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start;.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: pubertal (tanner stage 2 or greater);; concurrent addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;; receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;.

How the Study Was Run

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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

It started in 2009-06 with completion listed for 2012-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days (time frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days).

It also tracked 1 secondary outcome, for example Occurrence of Hypoglycemia;.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 16 people.

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

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, all human trials.