A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus

What Was Tested

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

This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).

Both drugs will be given by injection under the skin of the abdomen.

This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 31 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening. Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination.

How the Study Was Run

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

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-17 with completion listed for 2018-06-23.

It ran at 1 site in Japan.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Treatment Arm.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 31 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.