Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments.

It had two arms (groups): Trial part 1 (experimental) and Trial part 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 59 actual participants took part.

It was open to men only aged from 18 years up to 69 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:. Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months. Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive). ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:. Diagnosed with type 2 diabetes mellitus for at least 12 months.

The full record lists 9 inclusion and 2 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2006-09 with completion listed for 2007-02.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes). Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes).

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

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 59 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.