A Study of LY900014 in Participants With Type 2 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 2 diabetes mellitus.

The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

Screening is required within 28 days prior to the start of the study.

It had two arms (groups): LY900014 (experimental) and Insulin Lispro (Humalog) (active comparator).

The registry classes the interventions as drug.

Who Took Part

38 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year. Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²). Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%). Have had no episodes of severe hypoglycaemia in the last 6 months.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: have a history of renal impairment; have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives; have proliferative retinopathy or maculopathy and/or severe neuropathy.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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 2017-10-11 with completion listed for 2017-12-14.

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 38 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.