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ACTIVE NOT RECRUITING
NCT06767761
PHASE3

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

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 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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2025-02-18

Completion Date

2026-04-09

Last Updated

2025-11-25

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China