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

NCT07653477 | Not Yet Recruiting Phase 3

• 1 other identifier: TUL-UBT251（III-3）202603
• Study Type: interventional
• Target: 956
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c from Baseline

  Week 36

Secondary Outcomes (7)

• Body weight

  Week 36

• HbA1c

  Week 36

• HbA1c

  Week 36

• HbA1c

  Week 24, Week 52

• Body weight

  Week 24,Week 52

Study Arms (4)

UBT251 Injection 2.0mg group

EXPERIMENTAL

Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.

Drug: UBT251 Injection 2.0 mg group

UBT251 Injection 4.0mg group

EXPERIMENTAL

Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.

Drug: UBT251 Injection 4.0 mg group

UBT251 Injection 6.0mg group

EXPERIMENTAL

Each participants will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks.

Drug: UBT251 Injection 6.0 mg group

Semaglutide Injection 1mg group

ACTIVE COMPARATOR

S.C. once weekly

Drug: Semaglutide Injection

Interventions

UBT251 Injection 2.0 mg group DRUG

UBT251 Injection subcutaneously once weekly

UBT251 Injection 2.0mg group

UBT251 Injection 4.0 mg group DRUG

UBT251 Injection subcutaneously once weekly

UBT251 Injection 4.0mg group

UBT251 Injection 6.0 mg group DRUG

UBT251 Injection subcutaneously once weekly

UBT251 Injection 6.0mg group

Semaglutide Injection DRUG

Semaglutide Injection subcutaneously once weekly

Semaglutide Injection 1mg group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<5%, based on participant's report);
• Participants (including their partners) with no plan for pregnancy from screening until 6 months after completion of the study, willing to use contraceptive measures, and with no plan to donate sperm or ova within 6 months after study completion;
• Participants who have been fully informed about the study and have voluntarily signed written informed consent.

You may not qualify if:

• Known history of hypersensitivity to the investigational medicinal product or its excipients or other similar active drugs;
• Treatment with any of the following medications within 3 months prior to screening:
• Other antidiabetic medications except background therapy (short-term insulin use ≤14 days for acute conditions is allowed, e.g., perioperative period or hospitalization);
• Medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (excluded if cumulative use \<7 days and the end of treatment is \>7 half-lives prior to the first day of screening);
• Weight-loss medications (including but not limited to orlistat, semaglutide, or other similar prescription or over-the-counter drugs for weight loss).
• History or evidence of any of the following diseases:
• Diagnosis of other types of diabetes: such as Type 1 diabetes mellitus, special types of diabetes (e.g., genetic defects in β-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, etc.);
• History of acute or chronic pancreatitis, or pancreatic surgery;
• History of symptomatic gallbladder disease within 1 year prior to screening (participants who have undergone cholecystectomy \[completed at least 3 months prior to screening\] without long-term complications are excluded); or abdominal ultrasound at screening indicating large gallbladder stones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the investigator comprehensively determines may affect participant safety;
• Personal or family history (first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
• History of hematological disorders that may affect HbA1c test results or increase participant risk (e.g., aplastic anemia, myelodysplastic syndrome, etc.), or any disease causing hemolysis or red blood cell instability (e.g., sickle cell disease, thalassemia, etc.);
• History of moderate to severe depression or history of severe psychiatric disorders (including but not limited to suicidal ideation or suicide attempt, schizophrenia, bipolar disorder, etc.);
• History of clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:
• Myocardial infarction (MI) or unstable angina;
• Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention);

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Population Groups; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Haiyan Zhang

CONTACT

+86 18998165570; zhanghy@tul.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share