Actively Recruiting
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-01-09
800
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive
- Diagnosed with type 2 diabetes mellitus for at least 3 months before screening
- HbA1c between 7.5% and 11.0% at screening
- Stable treatment with metformin at a dose of 1500 mg/day or more for at least 8 weeks before screening
- Undergoing conventional lifestyle intervention
You will not qualify if you...
- Known or suspected allergy to the study drug or its components
- Diagnosis or suspicion of type 1 diabetes, special types of diabetes, or secondary diabetes
- History of acute diabetes complications (such as diabetic ketoacidosis, lactic acidosis, or hyperglycaemic hyperosmolar state) within 6 months before screening
- Presence of severe diabetic eye disease, painful diabetic nerve damage, diabetic foot ulcers, or intermittent claudication requiring acute treatment
- Pregnancy, breastfeeding, planning pregnancy during the trial, or inadequate use of contraceptives for women of childbearing potential or male participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jian Lei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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