Status:
RECRUITING
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Lead Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.
Eligibility Criteria
Inclusion
- 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
- Known or suspected allergy to the investigational drug or its components or excipients.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
- Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06589765
Start Date
September 27 2024
End Date
July 18 2026
Last Update
January 9 2025
Active Locations (1)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730