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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
HS-20094 injected subcutaneously once weekly
HS-20094 Placebo injected subcutaneously once weekly
HS-20094 injected subcutaneously once weekly
Beijing Hospital
Beijing, Beijing Municipality, China
Change in HbA1c
Change from baseline in HbA1c after 44 weeks of treatment
Time frame: Week 0 to Week 44
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
Time frame: Week 0 to Week 44
Change in FPG
Change from baseline in FPG after 44 weeks of treatment
Time frame: Week 0 to Week 44
Change in body weight
Change from baseline in Change in body weight after 44 weeks of treatment
Time frame: Week 0 to Week 44
Proportion of subjects with weight loss ≥5% and ≥10%
Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment
Time frame: Week 0 to Week 44
Change in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment
Time frame: Week 0 to Week 52
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 52 weeks of treatment
Time frame: Week 0 to Week 52
Change in FPG
Change from baseline in FPG after 52 weeks of treatment
Time frame: Week 0 to Week 52
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HS-20094 Placebo injected subcutaneously once weekly
Change in body weight
Change from baseline in Change in body weight after 52 weeks of treatment
Time frame: Week 0 to Week 52
Proportion of subjects with weight loss ≥5% and ≥10%
Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment
Time frame: Week 0 to Week 52
Incidence and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator
Time frame: Week 0 to Week 52+4 weeks follow-up