Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

It had two arms (groups): GLU_ASP (experimental) and ASP_GLU (experimental).

Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin glulisine Second day: insulin aspart.

Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin aspart Second day: insulin glulisine.

The registry classes the interventions as drug.

More on the Plan

Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).

Who Took Part

Enrollment: 64 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Type 1 diabetes mellitus. CSII for at least 3 months. Duration of diabetes \> 1 years.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: concomitant dietary restrictions (e.g. celiac disease or food allergy); diabetes related complications; any disease judged by the investigator to affect the trial.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-09 with completion listed for 2012-09.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Postprandial glycemia (time frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast).

It also tracked 4 secondary outcomes, for example Hypoglycemia episodes, Glucose Area Under the Curve (AUC), Mean amplitude of glycemic excursion (MAGE) and Difference between the maximum and baseline glycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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