A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The study is expected to last up to approximately 9 weeks for each participant.

It had two arms (groups): Insulin Lispro A (active comparator) and Insulin Lispro B (experimental).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are healthy males or females. Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m\^2). Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: history of first-degree relatives known to have diabetes mellitus; evidence of an acute infection with fever or infectious disease; intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).

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 2014-05 with completion listed for 2014-08.

It ran at 1 site in Singapore.

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.