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

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.

Inclusion Criteria: * Aged 18 to 75 years (inclusive) at the time of signing informed consent, with no restriction on gender; * Diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the 2019 World Health Organization (WHO) criteria (Appendix 1), with glycated hemoglobin (HbA1c) ≥7.5% and ≤11.0%; * Participants with inadequate glycemic control despite stable treatment for 3 months prior to screening with 1) metformin; or 2) metformin in combination with sulfonylurea; or 3) metformin in combination with sodium-glucose cotransporter 2 (SGLT2) inhibitor, with the following dosage requirements: Metformin: ≥1500 mg/day or maximum tolerated dose (at least ≥1000 mg/day); Sulfonylurea: half of the maximum daily dose as specified in the package insert or maximum tolerated dose (see Appendix 2 for details); SGLT2 inhibitor: daily dose approved in the package insert (see Appendix 2 for specific products and dosage requirements). * Body mass index (BMI) ≥23.0 kg/m² at screening, with stable body weight for 3 months prior to screening (change \470 ms for female participants or \>450 ms for male participants (calculation formula see Appendix 5); 3. Pre-excitation syndrome (Wolff-Parkinson-White syndrome); 4. Heart rate \100 beats/min; 5. Other serious arrhythmias requiring treatment; 10. Positive hepatitis B surface antigen with hepatitis B virus deoxyribonucleic acid (HBV-DNA) exceeding the upper limit of the reference range, or positive hepatitis C virus antibody with hepatitis C virus ribonucleic acid (HCV-RNA) exceeding the upper limit of the reference range, or positive human immunodeficiency virus (HIV) antibody, or positive both specific and non-specific syphilis antibodies; 11. Abnormalities in physical examination, vital signs, laboratory tests, etc. that are clinically significant and assessed by the investigator as potentially posing significant risk to participants or interfering with the evaluation of safety, PK, or PD results, making them unsuitable for participation in this study. * Participation in other interventional clinical trials within 3 months prior to screening (excluding those who only participated in screening but were not enrolled, or those who were enrolled but did not receive treatment); * Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion; * Lactating women or pregnant women;