A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects

What Was Tested

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

This trial is conducted in Europe.

It had 1 arm (groups): FIAsp (experimental).

Each subject will be randomised to a treatment sequence consisting of 5 treatment periods.

The registry classes the interventions as drug.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female, aged 18-64 years both inclusive at the time of signing informed consent. Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator. Body mass index 20.0-28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily); not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-03-17 with completion listed for 2014-06-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration) (time frame: From 0 to 12 hours).

It also tracked 2 secondary outcomes, for example Area under the serum insulin aspart concentration-time curve (only for intramuscular administration) and Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 21 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.