Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe and the United States of America (USA).

It had two arms (groups): Faster-acting insulin aspart CSII (experimental) and NovoRapid® CSII (active comparator).

The registry classes the interventions as drug.

Who Took Part

472 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.

Examples of who could join: Male or female, age at least 18 years at the time of signing the informed consent. Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening. Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: planned coronary, carotid or peripheral artery revascularisation known on the day of screening; history of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening; any condition which, in the opinion of the investigator, might jeopardise a subject's safety or compliance with the protocol.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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 2016-07-06 with completion listed for 2017-06-20.

It ran at 92 sites in United States (30), France (10), Netherlands (10), Russia (10), Germany (9) and Canada (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 16).

It also tracked 90 secondary outcomes, for example Change From Baseline in 1-hour PPG Increment, Change From Baseline in 1,5-anhydroglucitol, Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test), Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) and Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 472 people.

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.