Clinical Trial

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

Study acronym: UNIGUIDE-2
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07653477
Lead Sponsor The United Bio-Technology (Hengqin) Co., Ltd.
Conditions Type 2 Diabetes
Enrollment 956 participants
Start Date 2026-07-30
Primary Completion 2028-02-29 (estimated)
Study Completion 2028-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-17