A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe and in the United States of America (USA).

The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.

It had five arms (groups): NN1218, formulation A (experimental), NN1218, formulation B (experimental), NN1218, formulation C (experimental), NN1218, formulation D (experimental) and insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 82 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 or type 2 diabetes mellitus for more than 12 months. Body Mass Index (BMI) between 18.0-32.0 kg/m2 (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

Design: randomized, crossover and double-blind.

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.

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 2010-04 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the blood glucose concentration-time curve (time frame: from 0-2 hours).

It also tracked 1 secondary outcome, for example Area under the blood glucose concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 82 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.