This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
Males and females, Age ≥18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
7.5% ≤ HbA1c ≤10.5% at screening.
Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
Parallel
HS-20094 Injection
DrugHS-20094 injected subcutaneously once weekly
HS-20094 Placebo Injection
DrugHS-20094 Placebo injected subcutaneously once weekly
HS-20094 Injection
DrugHS-20094 injected subcutaneously once weekly
HS-20094 Placebo Injection
DrugHS-20094 Placebo injected subcutaneously once weekly
Change in HbA1c
Change from baseline in HbA1c after 44 weeks of treatment
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 44 weeks of treatment
Change in FPG
Change from baseline in FPG after 44 weeks of treatment
Change in body weight
Change from baseline in Change in body weight after 44 weeks of treatment
Proportion of subjects with weight loss ≥5% and ≥10%
Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment
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