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
Recruiting
Apply to this trial

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 40 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

First listed
Jun 17, 2026
Start date
Sep 7, 2026
Status verified
Sep 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 40 ]

Central Contacts

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies