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

Summary

This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 in Combination with Insulin Aspart (with or without Non-Insulin Antidiabetic Agents) in Subjects with Type 2 Diabetes Mellitus (T2DM) Treated with Basal+Prandial Insulin Treatment

Timeline

Start

2025-02-18

Primary completion

2026-03-19

Completion

2026-04-09

Outcome

Met primary endpoint

release “SUPER-3, a pivotal Phase 3 clinical trial conducted in China evaluating investigative once-weekly basal insulin GZR4 Injection, have successfully met its pre-specified primary endpoint.” ganlee.com ↗

Drugs

Indications