A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

Sponsor
Gan and Lee Pharmaceuticals, USA
Study ID
NCT06202079
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GZR4 Injection — DRUG
    GZR4 injection 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 compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.

Key Dates

Start date
Aug 11, 2023
Status verified
Jan 2025
Primary completion
Jul 13, 2024
Completion
Aug 8, 2024

Study Design

Enrollment
179 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR4 Injection
    GZR4 Injection + Oral Antidiabetic Drug
  • Active Comparator: Insulin Degludec
    Insulin Degludec + Oral Antidiabetic Drug

Primary Outcome Measure

Change in HbA1c [ Time Frame: From baseline (week 0) to week 16 ]

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