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

What Was Tested

The trial (not phased) is built around Insulin Lispro.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 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

The set-up was randomized, crossover and quadruple-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.

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, care provider, investigator and outcomes assessor.

It started in 2016-08-22 with completion listed for 2016-12-26.

It ran at 1 site in Russia.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Cmax. AUC(0-t). GIRmax.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 28 people.

Its size is small, so on its own it can only give an early look.

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.