Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Japan.

It had four arms (groups): Treatment sequence 1 - IM treatment group (experimental), Treatment sequence 2 - IM treatment group (experimental), Treatment sequence 1 - IV treatment group (experimental) and Treatment sequence 2 - IV treatment group (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 20 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. Treated with multiple daily insulin injections for at least 12 months. Body Mass Index (BMI) 18.0-28.0 kg/m\^2.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: subject who smokes more than 10 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 open-label study.

Because people in this Insulin (regular human) 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 (regular human) and the comparison in turn, acting as their own control.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01 with completion listed for 2011-03.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clearance at steady state (CLss) for IV treatment group (time frame: from 180 min to 240 min). Area under the curve (AUC) for IM treatment group (time frame: from 0 to 480 min after intramuscular injection).

It also tracked 4 secondary outcomes, for example Area under the curve (AUC) for IM treatment group, Steady state concentration (Css) for IV treatment group, Hypoglycaemic episodes and Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Aspart in 13 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 (regular human) compound page and the Insulin Aspart compound page, all human trials.