Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population

What Was Tested

This registered phase 3 trial tested Insulin (regular human) and Insulin Aspart.

This trial is conducted in the United States of America (USA).

The registry classes the interventions as drug.

Who Took Part

The registry lists 378 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pediatric patients with Type 1 diabetes for at least one year. Willing to administer at least 3 injections per day. Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group 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.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2002-06 with completion listed for 2004-06.

It ran at 76 sites in United States (76).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (glycosylated haemoglobin A1c).

It also tracked 1 secondary outcome, for example FPG (fasting plasma glucose).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 378 people.

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.