NCT06202079

A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

A Phase 2 Clinical Trial Comparing the Efficacy and Safety of Once-weekly GZR4 Injection Versus Once-daily Insulin Degludec in Subjects with Type 2 Diabetes Mellitus on OAD Therapy or OAD Therapy in Combination with Basal Insulin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	GZR4 Injection	GZR4 injection s.c., once-weekly, treat-to-target dose
DRUG	Insulin Degludec	Insulin Degludec s.c., once-daily, treat-to-target dose

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-07-13
• Completion: 2024-08-08
• First posted: 2024-01-11
• Last updated: 2025-01-23

Locations

8 sites across 1 country: China