A Study of a New LY900014 Formulation in Healthy Participants

What Was Tested

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

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar.

It is administered by injection under the skin of the abdomen.

The registry classes the interventions as drug.

Who Took Part

24 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). Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive, at screening. Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: have previously participated or withdrawn from this study.

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.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant.

It started in 2015-08 with completion listed for 2015-10.

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 24 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.