2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
155
The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangdong, Guangzhou, China
Change in HbA1c from baseline at Week 16
Time frame: Week 16
Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks
Time frame: 16 weeks
Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks
Time frame: 16 weeks
The change in fasting blood glucose from baseline to 16 weeks
Time frame: 16 weeks
The change in in body weight from baseline to 16 weeks
Time frame: 16 weeks
The change in 7-point SMBG profile from baseline to 16 weeks
Time frame: 16 weeks
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