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

Phase 3 Active not recruiting 620 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 Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.

Timeline

Start: 2025-02-15
Primary completion: 2026-02-07
Completion: 2026-02-28

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GZR4	Unknown	—	Subcutaneous
Comparator	insulin degludec	Protein / enzyme biologic	—	Subcutaneous

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

Summary

Timeline

Drugs

Indications