Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05950516
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

Key Dates

Start date
Jul 10, 2023
Status verified
Jul 2023
Primary completion
Nov 24, 2024
Completion
Jan 22, 2025

Study Design

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

Arms

  • Experimental: QLG2065
    Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
  • Active Comparator: Ozempic
    Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 33 ]

Central Contacts

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