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ACTIVE NOT RECRUITING
NCT06767748
PHASE3

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

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

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.

Official title: A Phase III Clinical Study Comparing the Efficacy and Safety of Once-weekly GZR4 Versus Once-daily Insulin Degludec With or Without Non-Insulin Antidiabetic Agents in Subjects With Type 2 Diabetes Mellitus (T2DM) Treated With Basal Insulin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2025-02-15

Completion Date

2026-02-28

Last Updated

2025-11-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

GZR4

GZR4 s.c., once-weekly,treat-to-target dose

DRUG

insulin degludec

insulin degludec s.c.,once-daily,treat-to-target dose

Locations (1)

Gan & Lee Pharmaceuticals Shandong Co., Ltd.

Linyi, Shandong, China