Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes

What Was Tested

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

The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe).

Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance.

It had two arms (groups): Faster aspart (experimental) and Insulin aspart (active comparator).

4 daily injections of faster aspart given with insulin degludec and with or without metformin.

4 daily injections of insulin aspart given with insulin degludec and with or without metformin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 331 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Male or female, age above or equal to 18 years at the time of signing informed consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: subjects presently classified as being in new york heart association (nyha) class iv; planned coronary, carotid or peripheral artery revascularisation known on the day of screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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 2020-10-09 with completion listed for 2022-07-05.

It ran at 40 sites in China (38) and Hong Kong (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) (time frame: Baseline (week 0), week 16). Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) (time frame: Baseline (week 0), week 16).

It also tracked 27 secondary outcomes, for example Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test), Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test), Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile, Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) and Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 331 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.