Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart 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.

The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 42 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: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent. Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening. Body mass index 18.5-28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 2 exclusion criteria.

How the Study Was Run

The set-up was 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 2015-10-06 with completion listed for 2016-04-25.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean change in plasma glucose concentration (time frame: From 0-1 hour after trial product administration).

It also tracked 2 secondary outcomes, for example Rate of endogenous glucose production and Area under the serum insulin aspart concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 42 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.