Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Aspart.

It had two arms (groups): GZR101-80 (experimental) and GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30) (active comparator).

The registry classes the interventions as drug.

Who Took Part

345 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: At the age of 18-75 (inclusive) at the time of informed consent, male or female. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: grade 3 hypoglycemia within 3 months before screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2026-04-10 with completion listed for 2027-02-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment (time frame: Baseline , 16 weeks).

It also tracked 2 secondary outcomes, for example Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment and Safety Endpoints.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 345 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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