A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

It had two arms (groups): FIAsp (experimental) and NovoRapid® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 6 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female aged 6-64 years (both inclusive) at the time of signing informed consent. Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m\^2.

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 double-blind.

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.

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 2014-01-13 with completion listed for 2014-07-24.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the serum insulin aspart concentration-time curve (time frame: From 0 to 12 hours).

It also tracked 1 secondary outcome, for example 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 41 people.

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.