Study S002005

A Multicenter, Randomized, Open-Label, Semaglutide Injection-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of UBT251 Injection in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With Metformin Alone or in Combination With Sulfonylurea/Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Therapy (UNIGUIDE-2)

ClinicalTrials.gov record

Registration

Registration: NCT07653477
Acronym: UNIGUIDE-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: RECRUITING
Enrollment: 956
Start: 2026-09-07
Primary completion: 2028-02-29
Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:UBT251 Injection 2.0 mg group; DRUG:UBT251 Injection 4.0 mg group; DRUG:UBT251 Injection 6.0 mg group; DRUG:Semaglutide Injection
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

HbA1c [Week 40]

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