Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe.

Each subject will be randomised to four out of nine possible treatment arms.

It had nine arms (groups): IDegAsp 30 + placebo (experimental), Insulin aspart + insulin degludec - low concentration 1 (experimental), IDegAsp 40 + placebo (experimental), Insulin aspart + insulin degludec - high concentration 1 (experimental) and IDegAsp 45 + placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

55 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: Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months. Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 3 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

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 2008-04 with completion listed for 2008-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the insulin aspart concentration curve.

It also tracked 2 secondary outcomes, for example Area under the glucose infusion rate curve and Area under the serum insulin 454 concentration curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 55 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.