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.
Study ID
NCT06767748
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GZR4 — DRUG
    GZR4 s.c., once-weekly，treat-to-target dose
  • insulin degludec — DRUG
    insulin degludec s.c.,once-daily，treat-to-target dose

Study Details

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.

Key Dates

Start date
Feb 15, 2025
Status verified
Apr 2025
Primary completion
Feb 7, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
620 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR4 group
  • Active Comparator: insulin degludec group

Primary Outcome Measure

Change in HbA1c [ Time Frame: From baseline (week 0) to week 26 ]

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