Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted globally.

It had three arms (groups): Meal-time faster-acting insulin aspart and insulin degludec (experimental), Meal-time NovoRapid® (insulin aspart) and insulin degludec (active comparator) and Post-meal faster-acting insulin aspart and insulin degludec (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 834 actual participants took part.

It was open to people of any sex aged from 1 Year up to 17 years.

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

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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 2016-05-04 with completion listed for 2018-02-05.

It ran at 155 sites in United States (38), Japan (36), India (10), Russia (10), Ukraine (9) and Germany (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the Percentage of HbA1c (time frame: Week 0, Week 26).

It also tracked 79 secondary outcomes, for example Change in 8-point SMPG Profile: Mean PPG Over All Three Meals, Change in 8-point SMPG Profile: PPG Increment Over All Three Meals, Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG, Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment, Change in 8-point SMPG Profile: Mean of the 8-point Profile and Fluctuation in the 8-point SMPG Profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 834 people.

With 834 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.