The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
546
HS-20094 injected subcutaneously once weekly
Dulaglutide injected subcutaneously once weekly
Shandong Provincial Hospital
Jinan, Shandong, China
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Tianjin, Tianjn, 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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