A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar.

The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal.

For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.

It had four arms (groups): LY900014 Before Meal (experimental), LY900014 After Meal (experimental), Insulin Lispro (Humalog) Before Meal (active comparator) and Insulin Lispro (Humalog) After Meal (active comparator).

The registry classes the interventions as biological.

Who Took Part

The registry lists 36 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: Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m². Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research; are treated with a csii (insulin pump).

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.

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 2017-11-13 with completion listed for 2018-03-31.

It ran at 2 sites in Germany (2).

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 36 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.