Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

What Was Tested

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

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained after being advised of the nature of the study. Male or female aged 18-60 years (both inclusive). Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months. Body mass index 20.0-28.0 kg/m² (both inclusive).

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods; skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator; history of bleeding disorder.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2011-04 with completion listed for 2011-06.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: tmax(ins), time to maximum observed serum insulin aspart concentration (time frame: 8 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 12 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.