drugset / Trial / NCT06202079

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

NCT06202079 ↗

Phase 2 Completed 179 enrolled Gan and Lee Pharmaceuticals, USA
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-11
Primary completion
2024-07-13
Completion
2024-08-08

Outcome

Met primary endpoint

release “In part B, GZR4 injection demonstrated a superior HbA1c reduction of 1.26%, compared to -0.87% for insulin degludec (treatment difference: -0.38%, p < 0.01)” ganlee.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GZR4 Unknown — Subcutaneous
Comparator insulin degludec Protein / enzyme biologic — Subcutaneous