A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Aspart.

This trial is conducted in China.

It had two arms (groups): GZR101 (experimental) and insulin degludec/insulin aspart, (active comparator).

The registry classes the interventions as drug.

Who Took Part

153 actual participants took part.

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: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. BMI = 18.5-35 kg/m2 (inclusive) at screening. Diagnosed with type 2 diabetes mellitus for ≥ 6 months.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: women in pregnancy or lactation; subjects with any malignancy diagnosed prior to screening or documented history of malignancy; those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2023-11-21 with completion listed for 2024-06-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Baseline to week 16).

It also tracked 5 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Incidence and Rate of hypoglycemia Events, Incidence and Rate of Treatment-emergent AE/SAEs and Change from baseline in ADA and Nab.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 153 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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