A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 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): NN1218 (experimental) and insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 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 for more than 12 months. Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months. Body mass index (BMI) between 18.0-28.0 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

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.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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 2011-11 with completion listed for 2012-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the serum insulin aspart concentration-time curve (time frame: From 0 to 1 hour).

It also tracked 3 secondary outcomes, for example Area under the serum insulin aspart concentration-time curve, Maximum observed serum insulin aspart concentration and Time to maximum observed serum insulin aspart concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 40 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.