Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

What Was Tested

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

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe).

Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance.

It had two arms (groups): Faster aspart + insulin degludec with or without metformin (experimental) and NovoRapid/NovoLog + insulin degludec with or without metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

1264 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 quadruple-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, care provider, investigator and outcomes assessor.

It started in 2017-09-19 with completion listed for 2019-01-07.

It ran at 167 sites in United States (64), Canada (11), South Korea (10), Greece (8), Russia (8) and Spain (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 51 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 (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]), Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) and Change From Baseline in Mean of the 7-9-7 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 1264 people.

With 1264 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.