A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe.

It had two arms (groups): Formulation 1 (experimental) and Formulation 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

32 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 12 months or longer. Body mass index from 18.0 to 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 more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period.

How the Study Was Run

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

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.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-10 with completion listed for 2012-01.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin degludec concentration-time curve. Maximum observed serum insulin degludec concentration. Area under the serum insulin aspart concentration-time curve.

It also tracked 2 secondary outcomes, for example 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 32 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.