A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus.

The study will investigate how the body processes the drug and how the drug affects the body.

Information about side effects will be collected.

It had two arms (groups): LY900027 (experimental) and Insulin Lispro (active comparator).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Diagnosis of T1DM for at least 1 year. Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L). Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²).

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-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.

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 2019-12-27 with completion listed for 2020-07-14.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK: Maximum Observed Insulin Lispro Concentration (Cmax).

It also tracked 3 secondary outcomes, for example Duration Until Catheter Failure.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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