A Study of LY900014 Formulations in Healthy Participants

What Was Tested

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

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen.

The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels.

Side effects and tolerability were documented.

It had six arms (groups): Part A: LY900014 Test A (experimental), Part A:Insulin Lispro (experimental), Part A: LY900014 Test B (experimental), Part A: LY900014 Test C (experimental) and Part A: LY900014 Test D (experimental).

The registry classes the interventions as biological.

Who Took Part

The registry lists 29 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The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: have previously participated or withdrawn from this study.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 double-blind.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-01 with completion listed for 2015-04.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 4 secondary outcomes, for example Part A: Visual Analog Scale (VAS) Score for Injection Site Pain, Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp and Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 29 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.