A Study of LY900014 in Healthy Chinese Participants

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar.

The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels.

For each participant, the study will consist of 3 periods and will last about 51 days.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Are overtly healthy native Chinese males or females. Women not of child-bearing potential who are infertile or post-menopausal. Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²).

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product; have previously completed or withdrawn from this study or any other study investigating ly900014; have known allergies to ly900014 or any components of the formulation.

How the Study Was Run

Design: randomized, crossover and single-blind.

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

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

In this single-blind Insulin Lispro study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2019-11-18 with completion listed for 2020-10-23.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 15 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.