A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

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

It had two arms (groups): GZR4 group (experimental) and Insulin Glargine U100 group (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 580 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males and females age ≥ 18 years at the time of informed consent. The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization. Naive to insulin treatment.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: subjects who are pregnant, lactating or planning to become pregnant during the study at screening; the patient with sbp ≥ 160 mmhg or dbp ≥ 100 mmhg during screening.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2025-02-17 with completion listed for 2026-08-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: From baseline (week 0) to week 26).

It also tracked 4 secondary outcomes, for example Change in HbA1c, hypoglycaemia events, adverse events and Change in weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 580 people.

With 580 participants it is a large trial for this field.

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

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