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

A Phase III Clinical Study Comparing the Efficacy and Safety of Once-weekly GZR4 Versus 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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	GZR4	GZR4 s.c., once-weekly，treat-to-target dose
DRUG	Insulin Glargine U100 group	Insulin Glargine U100 s.c.,once-daily，treat-to-target dose

Timeline

• Start date: 2025-02-18
• Primary completion: 2026-03-19
• Completion: 2026-04-09
• First posted: 2025-01-10
• Last updated: 2025-11-25

Locations

1 site across 1 country: China