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;
Parallel
UBT251 Injection 2.0 mg
DrugUBT251 Injection subcutaneously once weekly
UBT251 Injection 4.0 mg
DrugUBT251 Injection subcutaneously once weekly
UBT251 Injection 6.0 mg
DrugUBT251 Injection subcutaneously once weekly
UBT251 Injection Placebo 2.0 mg
DrugUBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 4.0 mg
DrugUBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 6.0 mg
DrugUBT251 Injection placebo subcutaneously once weekly
6
Treatment groupsSee each treatment group below.
HbA1c
Change in HbA1c from Baseline
Proportion of participants with HbA1c <7.0%，HbA1c ≤6.5% and <5.7
Proportion of participants with HbA1c \<7.0%，HbA1c ≤6.5% and \<5.7 from baseline
Body weight
Percent change in body weight from baseline
Proportion of participants with body weight reduction ≥5%
Proportion of participants with body weight reduction ≥5% from baseline
Proportion of trial participants with HbA1c <7.0% and body weight reduction ≥5%
Proportion of trial participants with HbA1c \<7.0% and body weight reduction ≥5% from baseline
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