Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT07527078
Phase
PHASE3
Status
Recruiting
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Conditions

  • Type 2 Diabetes (T2DM)

Eligibility Criteria

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

Interventions

  • GZR33 Injection — DRUG
    GZR33 Injection Administered SC, once-daily
  • Insulin Degludec Injection (Tresiba®) — DRUG
    Administered SC, once-daily

Study Details

Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.

Key Dates

First listed
Apr 14, 2026
Start date
Apr 7, 2026
Status verified
Apr 2026
Primary completion
Apr 7, 2026
Completion
Apr 17, 2027

Study Design

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

Arms

  • Experimental: GZR33 Injection
  • Active Comparator: Insulin Degludec Injection (Tresiba®)

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) from baseline after 26 weeks of treatment. [ Time Frame: Baseline , 26 weeks ]

Central Contacts

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