A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).

It had three arms (groups): Insulin Lispro (Humalog) (active comparator), LY900014 (experimental) and LY900014 Postmeal (experimental).

The registry classes the interventions as drug.

Who Took Part

751 actual participants took part.

It was open to people of any sex aged from 1 Year up to 17 years.

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

Examples of who could join: T1D for at least 6 months at the screening visit. Insulin lispro U-100, or. Insulin glulisine or. Fast acting insulin aspart. Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:.

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit; have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2019-04-07 with completion listed for 2021-07-02.

It ran at 111 sites in United States (27), Russia (9), Spain (9), United Kingdom (7), China (6) and Czechia (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Change From Baseline in HbA1c (Postprandial) at Week 26, Percentage of Participants With Documented Hypoglycemic Events, Rate of Documented Hypoglycemia Events, Rate of Severe Hypoglycemia and Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 751 people.

With 751 participants it is a large trial for this field.

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

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.