Phase
Condition
Diabetes Prevention
Diabetes Mellitus Types I And Ii
Diabetes Mellitus, Type 2
Treatment
HRS-7535 tablet
dapagliflozin tablet
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 18-75 age years, both inclusive;
Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
HbA1c 7.5-11.0% (both inclusive) at screening;
Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
Exclusion
Exclusion Criteria:
Known or suspected allergy to the investigational drug or its components orexcipients.
Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes orsecondary diabetes.
Have a history of acute complications of diabetes (diabetic ketoacidosis, lacticacidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior toscreening.
Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic footulcer or intermittent claudication requiring acute treatment;
Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or womenof childbearing potential (WOCBP) or male subject not using adequate contraceptivemeasures.
Study Design
Connect with a study center
Beijing Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
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