Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

This trial was conducted in Europe.

It had six arms (groups): IDegAsp low (experimental), IDegAsp middle (experimental), IDegAsp high (experimental), BIAsp 30 low (experimental) and BIAsp 30 middle (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 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 18.0-28.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic; 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

Design: 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 2009-09 with completion listed for 2009-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area (AUC) under the glucose infusion rate curve.

It also tracked 1 secondary outcome, for example Area (AUC) under the insulin aspart concentration time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 33 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.