Clinical Trial

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

Active, Not Recruiting Phase 3
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Record status
This record was last updated November 25, 2025 (before its estimated March 19, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-05.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-11-20
Trial Details
NCT Number NCT06767761
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Diabetes
Enrollment 580 participants
Start Date 2025-02-18
Primary Completion 2026-03-19 (estimated)
Study Completion 2026-04-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-25