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

What Was Tested

The trial (phase 3) is built around Insulin Aspart.

This trial is conducted in Asia, Europe and North America.

It had three arms (groups): Mealtime faster-acting insulin aspart and insulin degludec (experimental), Mealtime NovoRapid® and insulin degludec (active comparator) and Postmeal faster-acting insulin aspart and insulin degludec (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1108 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Design: randomized, parallel-group and double-blind.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-05-04 with completion listed for 2017-07-17.

It ran at 152 sites in United States (57), Japan (24), India (17), Russia (12), Germany (8) and Bulgaria (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c 26 Weeks After Randomisation (time frame: Week 0, week 26).

It also tracked 48 secondary outcomes, for example Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test), Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation, Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation, Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation, Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation and Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 1108 people.

With 1108 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.