Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2)

Sponsor
The United Bio-Technology (Hengqin) Co., Ltd.
Study ID
NCT07653477
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • UBT251 Injection 2.0 mg group — DRUG
    UBT251 Injection subcutaneously once weekly
  • UBT251 Injection 4.0 mg group — DRUG
    UBT251 Injection subcutaneously once weekly
  • UBT251 Injection 6.0 mg group — DRUG
    UBT251 Injection subcutaneously once weekly
  • Semaglutide Injection — DRUG
    Semaglutide Injection subcutaneously once weekly

Study Details

This study is a multicenter, randomized, open-label, parallel-group, semaglutide injection-controlled clinical trial. It aims to evaluate the non-inferiority of UBT251 Injection in glycemic control compared with Semaglutide Injection after 36 weeks of continuous administration in study participants with Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control on oral antidiabetic medications.A total of 956 participants are planned to be enrolled, including the UBT251 Injection 2 mg group, 4 mg group, 6 mg group, and Semaglutide group，with an approximate study duration of 58 weeks per participant.

Key Dates

Start date
Jul 30, 2026
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: UBT251 Injection 2.0mg group
    Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.
  • Experimental: UBT251 Injection 4.0mg group
    Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.
  • Experimental: UBT251 Injection 6.0mg group
    Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.
  • Active Comparator: Semaglutide Injection 1mg group
    S.C. once weekly

Primary Outcome Measure

HbA1c [ Time Frame: Week 36 ]

Central Contacts

Related Studies