RecruitingPhase 3NCT07653477

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

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)

Sponsor

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

Enrollment

956 participants

Start Date

Sep 7, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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 40 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Semaglutide Injection, a drug called UBT251 Injection 2.0 mg group, and others for people with type 2 diabetes. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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