A Comparison Between Two Formulations of NN5401 in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

This trial is conducted in the United States of America (USA).

The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

It had two arms (groups): IDegAsp B (experimental) and IDegAsp F (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician. Body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2010-05 with completion listed for 2010-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the serum insulin degludec concentration-time curve. Maximum observed serum insulin degludec concentration. Area under the serum insulin aspart concentration-time curve.

It also tracked 2 secondary outcomes, for example Time to maximum observed serum insulin degludec concentration and Time to maximum observed serum insulin aspart concentration.

What This Means in Plain Language

Put simply, this is a phase 1, 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.