The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
884
HRS9531 injected subcutaneously once weekly.
Semaglutide injected subcutaneously once weekly.
Zhu Xianyi Memorial Hospital,Tianjin Medical University
Tianjin, Tianjin Municipality, China
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Change in body weight
Change from baseline in body weight after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Proportion of Subjects with HbA1c≤6.5%
Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Proportion of Subjects with HbA1c<7%
Proportion of subjects with HbA1c\<7% after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Change from baseline in FPG after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Change from baseline in FPG after 52 weeks of treatment.
Time frame: Week 0 to Week 52
7-points SMPG profiles
Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime.
Time frame: Week 0 to Week 36
Incidence and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator.
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Time frame: Week 0 to Week 52+4 weeks follow-up