Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

It had three arms (groups): Arm 1: Medication regimen A-B-C (experimental), Arm 2: Medication regimen B-C-A (experimental) and Arm 3: Medication regimen C-A-B (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female aged 18-64 years (both inclusive)；. Body mass index 18.5-35.0 kg/m2 (both inclusive)；. Diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening；.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator; have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;; proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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 2024-05 with completion listed for 2024-07-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum concentration-time curve of insulin aspart (time frame: From 0 to 30 mins after trial product administration).

It also tracked 3 secondary outcomes, for example Area under the serum concentration-time curve of insulin aspart, Plasma glucose concentration and Number of subjects with adverse events and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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