Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Insulin Aspart.

This trial is conducted in Europe.

It had two arms (groups): IAsp (experimental) and HI (active comparator).

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

It was open to people of any sex aged from 2 years up to 6 years.

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

Examples of who could join: Type 1 diabetes. Treatment with insulin for at least 6 months prior to inclusion. Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: the receipt of any investigational drug within one month prior to this trial; recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator; treatment with oral hypoglycaemic agents.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-06-19 with completion listed for 2003-10-15.

It ran at 6 sites in Germany (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of hypoglycaemic episodes during the treatment (time frame: Week 0; week 24). Change in HbA1c (glycosylated haemoglobin A1c) (time frame: Week 0; week 24).

It also tracked 1 secondary outcome, for example Incidence of Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 26 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 (regular human) compound page and the Insulin Aspart compound page, all human trials.