A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

It had two arms (groups): Faster Aspart (experimental) and Insulin Aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 61 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25. Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening.

The full record lists 3 inclusion and 2 exclusion criteria.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2016-10-14 with completion listed for 2017-12-21.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin aspart concentration-time curve (time frame: From 0 to 30 minutes).

It also tracked 3 secondary outcomes, for example Maximum observed serum insulin aspart concentration, Area under the glucose infusion rate curve and Maximum glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 61 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.