A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

It had three arms (groups): 3 mm needle (experimental), 3.5 mm needle (experimental) and 4 mm needle (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 46 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male, age at least 18 years at 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 (BMI) 28-39.9 kg/m\^2 (overweight to obese).

How the Study Was Run

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

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.

In this single-blind Insulin Aspart study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-10-27 with completion listed for 2016-01-28.

It ran at 1 site in Germany.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Area under curve insulin aspart measured in serum (time frame: During a maximum of 8 hours). Maximum concentration of insulin aspart measured in serum (time frame: During a maximum of 8 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 46 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.