A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
NCT07165223 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-11-25
Summary
This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.
Conditions
Interventions
- DRUG
-
GZR4
GZR4 s.c., once-weekly,treat-to-target dose
- DRUG
-
Insulin Icodec group
insulin Icodec s.c., once-weekly,treat-to-target dose
Sponsors & Collaborators
-
Gan & Lee Pharmaceuticals.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-17
- Primary Completion
- 2026-11-10
- Completion
- 2026-11-10
Countries
- China
Study Locations
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