A Study of Various Formulations of LY900014 in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Lispro.

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014.

It had five arms (groups): LY900014 Test B (experimental), LY900014 Test A (experimental), LY900014 Test C (experimental), LY900014 Test D (experimental) and Insulin Lispro (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 21 years up to 65 years.

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

Examples of who could join: Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion). Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening. Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study. Have veins suitable for easy blood collection and glucose solution infusion.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug; show signs of having an infection or infectious disease at the time of study entry.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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

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

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2015-12 with completion listed for 2016-02.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 26 people.

Its size is small, so on its own it can only give an early look.

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

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