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

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.

Timeline

Start

2026-07-30

Primary completion

2028-02-29

Completion

2028-02-29

Drugs

Indications