A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around 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

The registry lists 36 actual participants took part.

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

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

Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.5-28.0 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 substitute products during the inpatient period inpatient period.

How the Study Was Run

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

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 2013-08 with completion listed for 2013-11.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change in plasma glucose concentration (time frame: From 0-2 hours after administration).

It also tracked 2 secondary outcomes, for example Area under the serum insulin aspart concentration-time curve and Area under the serum insulin aspart concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 36 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.