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Type 2 DiabetesPhase 3UNIGUIDE-2NCT07653477

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 Phase 3 study testing UBT251 Injection 2.0 mg group, UBT251 Injection 4.0 mg group and UBT251 Injection 6.0 mg group in people with Type 2 Diabetes, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
UBT251 Injection 2.0 mg group, UBT251 Injection 4.0 mg group and UBT251 Injection 6.0 mg group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
956 participants
Where
1 siteChina
Study dates
7 Sep 2026to 29 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 45Show fewer
  • 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);
  • Congestive heart failure (New York Heart Association [NYHA] Class III-IV) (see Appendix 3 for details);
  • Cerebrovascular accident (excluding old lacunar infarction), including but not limited to hemorrhagic or ischemic stroke or transient ischemic attack;
  • Other cardiovascular or cerebrovascular diseases assessed by the investigator as unsuitable for participation in this study;
  • Severe retinal or macular lesions at screening (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.), and the investigator determines that further urgent treatment is required;
  • Severe hypoglycemia (hypoglycemia with severe cognitive impairment requiring other therapeutic measures to assist recovery) or recurrent symptomatic hypoglycemia (≥2 times within 6 months) within 6 months prior to screening;
  • History of acute metabolic complications of diabetes (including but not limited to diabetic ketoacidosis, hyperosmolar hyperglycemic state requiring hospitalization, hyperosmolar coma, lactic acidosis, etc.) or diabetic foot within 6 months prior to screening;
  • Concurrent gastrointestinal emptying disorders (e.g., gastroparesis, pyloric obstruction, intestinal obstruction, etc.) at screening, gastrointestinal diseases assessed by the investigator as increasing risk after administration (e.g., severe active ulcer, inflammatory bowel disease, acute gastroenteritis, uncontrolled gastroesophageal reflux disease, etc.), or history of major gastrointestinal surgery (gastrointestinal polypectomy, appendectomy, cholecystectomy, etc. that have completely recovered and are assessed by the investigator as not affecting study safety are excluded);
  • Major surgery, severe trauma, or severe infection within 1 month prior to screening, assessed by the investigator as unsuitable for participation in this study;
  • History of malignant tumors (excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, and assessed by the investigator as currently stable);
  • Concurrent other diseases, such as respiratory, urinary, neurological, hematological, immune system diseases, etc., and the investigator considers that they affect participant safety, efficacy evaluation, or compliance.
  • Screening results showing any of the following abnormal findings:
  • Hepatic or renal impairment: serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥3× upper limit of normal (ULN); serum total bilirubin (TBIL) ≥1.5×ULN; estimated glomerular filtration rate (eGFR) <45 mL·min-¹·1.73m-² (calculated according to the CKD-EPI 2021 equation, see Appendix 4);
  • Serum calcitonin ≥50 pg/mL (i.e., 50 ng/L);
  • Thyroid dysfunction not controlled with stable drug dosage, or clinically significant abnormalities in thyroid function test results at screening requiring initiation of treatment, or thyroid ultrasound at screening indicating thyroid nodules ≥TI-RADS 4a (or ≥TR4 according to the US classification standard) or assessed by the investigator as possibly requiring biopsy and/or surgery during the study period;
  • Fasting triglycerides ≥5.6 mmol/L;
  • Serum amylase and/or lipase >2.0×ULN;
  • International normalized ratio (INR) above the upper limit of the normal range;
  • Hemoglobin <100 g/L;
  • Untreated or poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, based on the mean of 3 blood pressure measurements during the screening period);
  • Clinically significant electrocardiogram (ECG) abnormalities, such as:
  • Second-degree or third-degree atrioventricular block;
  • Long QT syndrome, or QT interval corrected using Fridericia's formula (QTcF) >470 ms for female participants or >450 ms for male participants (calculation formula see Appendix 5);
  • Pre-excitation syndrome (Wolff-Parkinson-White syndrome);
  • Heart rate <50 beats/min or >100 beats/min;
  • Other serious arrhythmias requiring treatment;
  • 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;
  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Zhongshan Hospital,Fudan University

    Shanghai, 200032

    Recruiting

Other trials in China

About this study

Official title: 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)

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.

Conditions
Type 2 Diabetes
Being tested
UBT251 Injection 2.0 mg group, UBT251 Injection 4.0 mg group, UBT251 Injection 6.0 mg group, Semaglutide Injection
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UBT251 Injection 2.0 mg groupDrug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 4.0 mg groupDrug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 6.0 mg groupDrug

    UBT251 Injection subcutaneously once weekly

  • Semaglutide InjectionDrug

    Semaglutide Injection subcutaneously once weekly

Study groups in NCT07653477
Study groupRoleWhat they receive
UBT251 Injection 2.0mg groupExperimentalEach 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.
Receives: Drug: UBT251 Injection 2.0 mg group
UBT251 Injection 4.0mg groupExperimentalEach 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.
Receives: Drug: UBT251 Injection 4.0 mg group
UBT251 Injection 6.0mg groupExperimentalEach 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.
Receives: Drug: UBT251 Injection 6.0 mg group
Semaglutide Injection 1mg groupActive comparatorS.C. once weekly
Receives: Drug: Semaglutide Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Change in HbA1c from Baseline

    Measured: Week 40

Secondary outcomes (7)
  1. Body weight

    Percent change in body weight from baseline

    Measured: Week 40

  2. HbA1c

    Proportion of participants with HbA1c ≤6.5% and body weight reduction ≥10% from baseline

    Measured: Week 40

  3. HbA1c

    Proportion of participants with HbA1c ≤6.5%

    Measured: Week 40

  4. HbA1c

    Change in HbA1c from baseline

    Measured: Week 24, Week 32, Week 52

  5. Body weight

    Percent change in body weight from baseline

    Measured: Week 24,Week 32,Week 52

  6. HbA1c

    Proportion of participants with HbA1c ≤6.5%

    Measured: Week 24,Week 32,Week 52

  7. HbA1c

    Proportion of participants with HbA1c ≤6.5% and ≥10% body weight reduction from baseline

    Measured: Week 24,Week 32,Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start7 Sep 2026
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
956 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653477
Sponsor's protocol ID
TUL-UBT251(III-3)202603
Acronym
UNIGUIDE-2
Status last verified
Sep 2026
First submitted
12 Jun 2026
Last updated
14 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UBT251 Injection 2.0 mg group, UBT251 Injection 4.0 mg group and UBT251 Injection 6.0 mg group in people with Type 2 Diabetes, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haiyan Zhang (+86 18998165570, zhanghy@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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