Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT06161844
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • semaglutide injection (HD1916) — DRUG
    Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: HD1916
  • Ozempic® — DRUG
    Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: Ozempic Injectable Product

Study Details

To evaluate the similarity of the efficacy and safety of semaglutide injection (HD1916) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

Key Dates

Start date
Feb 23, 2024
Status verified
Oct 2024
Primary completion
May 14, 2025
Completion
May 14, 2025

Study Design

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

Arms

  • Experimental: Semaglutide injection (HD1916)
    Up to 1.0 mg semaglutide (HD1916) Metformin ≥ 1500 mg/day
  • Active Comparator: Ozempic®
    Up to 1.0 mg semaglutide (Ozempic®) Metformin ≥ 1500 mg/day

Primary Outcome Measure

Change from baseline to week 32 in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 32 ]

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