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ACTIVE NOT RECRUITING
NCT06767735
PHASE3

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)

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 Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.

Official title: A Phase III Clinical Study Comparing the Efficacy and Safety of GZR4 QW Versus Insulin Glargine U100 QD+ Non-Insulin Antidiabetic Agents in Insulin-naive Subjects With Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2025-02-17

Completion Date

2026-08-17

Last Updated

2025-11-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

GZR4

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

DRUG

Insulin Glargine U100

Insulin Glargine U100 s.c.,once-daily,treat-to-target dose

Locations (1)

Gan & Lee Pharmaceuticals Shandong Co., Ltd.

Linyi, Shandong, China