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

NCT07653477 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 956

Last updated 2026-06-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

UBT251 Injection 2.0 mg group

UBT251 Injection subcutaneously once weekly

DRUG

UBT251 Injection 4.0 mg group

UBT251 Injection subcutaneously once weekly

DRUG

UBT251 Injection 6.0 mg group

UBT251 Injection subcutaneously once weekly

DRUG

Semaglutide Injection

Semaglutide Injection subcutaneously once weekly

Sponsors & Collaborators

  • The United Bio-Technology (Hengqin) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2028-02-29
Completion
2028-02-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653477 on ClinicalTrials.gov