A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mix 25 to Humalog® Mix 25 in Healthy Subjects

What Was Tested

In this not phased trial, researchers set out to test Insulin Lispro.

It had two arms (groups): Insulin Lispro Mix 25 (experimental) and Humalog® Mix 25 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 48 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Signed informed consent. Caucasian males having a confirmed healthy diagnosis as per data of standard clinical, laboratory, and instrumental examination methods. Age of 18-50 (both incl.). Body mass index equal to 18.5-27.0 kg/m2. Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.

The full record lists 5 inclusion and 24 exclusion criteria; among the exclusions: acute inflammatory diseases within 3 weeks before the screening period; deep vein thrombosis of lower extremities in a history of life or in a family history; nicotine dependence (use of tobacco less than 6 months before the start of screening).

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-04-12 with completion listed for 2017-07-13.

It ran at 2 sites in Russia (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Cmax. AUC(0-t).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.