A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

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 Injection (experimental) and GZR33-70 Injection (experimental).

The registry classes the interventions as drug.

Who Took Part

60 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: 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female. 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening. 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: 1.presence or history of malignant neoplasm prior to screening; 2.known or suspected hypersensitivity to investigational medical product(s) or related products; 3.severe hypoglycemia (level 3 hypoglycemia) within 6 months prior to screening.

How the Study Was Run

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

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.

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

It started in 2024-06-28 with completion listed for 2024-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0, week 16).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Change in 7-point SMPG profile, Incidence and Rate of Treatment-emergent AE/SAEs and Incidence and Rate of hypoglycemia Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 60 people.

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.