A Study of LY900014 in a Medtronic Pump

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro.

The study will consist of two treatment periods of 4 weeks.

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 42 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: Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months. Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: participants must not have major problems with their heart, kidneys, liver, or have a blood disorder.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

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 2019-02-18 with completion listed for 2019-10-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Mean Sensor Glucose Value (24-Hour), Percentage of Time Spent in Auto Mode and Rate of Severe Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 42 people.

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.