A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy

What Was Tested

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

The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels.

Side effects and tolerability will be documented.

The study will be conducted in two parts (Part A and Part B) to achieve its objectives.

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

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin. Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening. Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study. Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party). Have venous access sufficient to allow for blood sampling.

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.

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-03 with completion listed for 2016-07.

It ran at 1 site in Germany.

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 30 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.