The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with diabetic kidney disease in type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
281
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Ratio of UACR at week 16 to UACR at baseline
Time frame: at Week 16
24 hour urine analysis results at Week 16
Time frame: at Week 16
Proportion of subjects with a 30% decrease in UACR from baseline at Week 16
Time frame: at Week 16
Change from baseline in eGFR at Week 16
Time frame: at Week 16
Change from baseline in HbA1c at Week 16
Time frame: at Week 16
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16
Time frame: at Week 16
Change from baseline in FPG at Week 16
Time frame: at Week 16
Change from baseline in insulin at Week 16
Time frame: at Week 16
Change from baseline in c-peptide at Week 16
Time frame: at Week 16
Change from baseline in body weight at Week 16
Time frame: at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16
Time frame: at Week 16
A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16
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Time frame: at Week 16