Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Gly… (NCT07659574) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）
China360 participantsStarted 2026-08-10
Plain-language summary
This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone
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.
Inclusion criteria
. Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria;
. Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening;
. Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening;
. Body mass index (BMI) ≥23.0 kg/m² at screening, and stable body weight (change \<5%, which may be based on the participant's self-report) within 3 months prior to screening;
. Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 IDNCT07659574
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.
. Have been fully informed about this study and voluntarily sign a written informed consent form.
Exclusion criteria
. Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
. History of medication use within 3 months prior to screening that meets any of the following conditions:
. Diagnosis of other types of diabetes: such as type 1 diabetes mellitus (T1DM), other specific types of diabetes (e.g., genetic defects in beta-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 before screening (excluding trial participants who have undergone cholecystectomy \[completed at least 3 months before screening\] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety;
. Personal or family history (within 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 the risk to trial participants (e.g., aplastic anemia, myelodysplastic syndromes, etc.), or any diseases causing hemolysis or erythrocyte instability (e.g., sickle cell disease, thalassemia, etc.);
. History of moderate to severe depression or severe psychiatric disorders (including but not limited to suicidal ideation or attempt, schizophrenia, bipolar disorder, etc.);