drugset / Trial / NCT06767761

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

NCT06767761

Phase 3 Active not recruiting 580 enrolled Gan & Lee Pharmaceuticals.
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject GZR4 Unknown Subcutaneous
Comparator insulin glargine Protein / enzyme biologic Subcutaneous