A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

What Was Tested

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

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study.

Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection.

It had four arms (groups): LY900014-Part A (experimental), Humalog (Insulin Lispro)-Part A (active comparator), LY900014-Part B (experimental) and Humalog (Insulin Lispro)-Part B (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 56 actual participants took part.

It was open to people of any sex aged from 6 years up to 64 years.

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

Examples of who could join: Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year. Have a glycated hemoglobin (HbA1c) less than (\<)10.0 percent (%).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening; more than one episode of severe hypoglycaemia in the last 6 months; have obvious clinical signs or symptoms of liver disease.

How the Study Was Run

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

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.

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 2018-03-26 with completion listed for 2019-11-14.

It ran at 2 sites in Canada (1) and Germany (1).

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 56 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.