A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects

What Was Tested

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

It had two arms (groups): Insulin Aspart (experimental) and NovoRapid® Penfill® (active comparator).

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

It was open to men only aged from 18 years up to 45 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 18-45 (both incl.). Body mass index equal to 18.5-30.0 kg/m2, body weight equal to 55.0-100.0 kg (both incl.). Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.

The full record lists 6 inclusion and 25 exclusion criteria; among the exclusions: weighed allergic anamnesis; any acute and chronic diseases, incl.:; of the cardiovascular system, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: outcomes assessor.

It started in 2018-10-18 with completion listed for 2018-12-19.

It ran at 2 sites in Russia (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: AUC(0-t). Cmax.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 26 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 Aspart compound page, all human trials.