A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Aspart and Insulin Lispro.

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin.

The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it.

A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products.

It had five arms (groups): LY900014 (experimental), Insulin Lispro (Humalog®) (active comparator), Insulin Aspart (NovoRapid®) (active comparator), Insulin Aspart (Fiasp®) (active comparator) and Healthy Participants (no intervention).

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year. Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²). Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%). Have had no episodes of severe hypoglycaemia in the last 6 months.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-03-15 with completion listed for 2018-08-14.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart and Insulin Lispro in 80 people.

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 and the Insulin Lispro compound page, all human trials.