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
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;
Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
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;
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Treatment groupsSee each treatment group below.