Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Con… (NCT07653477) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2)
956 participantsStarted 2026-07-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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).
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing UBT251 Injection on top of metformin, and possibly a sulfonylurea or SGLT2 inhibitor, would my current diabetes medications put me in a good position to even be considered for this study?
2Because this is a Phase III trial, what does my doctor know about the safety profile of UBT251 from earlier phases — and are there any side effects I should be aware of before deciding whether to explore this further?
3The trial is measuring HbA1c as its main outcome — how does the HbA1c reduction being studied here compare to what I might expect from simply adjusting or adding to my current standard treatment?
4Since this trial isn't recruiting yet, how long might I realistically wait before it opens, and is there a risk that waiting could leave my blood sugar poorly controlled in the meantime?
5Are there approved or well-established add-on medications for Type 2 Diabetes that my doctor would recommend I try first, or does my current level of glycemic control make a trial like this worth looking into sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HbA1c
Timeframe: Week 36
Trial details
NCT IDNCT07653477
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.
. 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.);