Study S002772

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）

ClinicalTrials.gov record

Registration

Registration: NCT07659574
Acronym: UNIGUIDE-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: RECRUITING
Enrollment: 360
Start: 2026-09-07
Primary completion: 2027-09-24
Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:UBT251 Injection 2.0 mg; DRUG:UBT251 Injection 4.0 mg; DRUG:UBT251 Injection 6.0 mg; DRUG:UBT251 Injection Placebo 2.0 mg; DRUG:UBT251 Injection Placebo 4.0 mg; DRUG:UBT251 Injection Placebo 6.0 mg
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

HbA1c [Week 40]

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