Actively Recruiting
Study Comparing HRS-7535 and Dapagliflozin Tablets in Adults with Type 2 Diabetes Inadequately Controlled with Metformin, Phase 3 Randomized Trial
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
Researchers are evaluating the safety and effectiveness of a drug called HRS-7535 compared with dapagliflozin in adults with type 2 diabetes who have not achieved adequate blood sugar control despite using metformin. This Phase 3, randomized, double-blinded study focuses on participants aged 18 to 75 years who have had type 2 diabetes for at least three months and meet specific blood sugar levels at screening. Participants will receive either HRS-7535 tablets or dapagliflozin tablets while continuing their stable metformin treatment. The study aims to assess changes in blood sugar control, specifically the change from baseline in HbA1c after 32 weeks of treatment. Both treatments are given as oral tablets, and the study design ensures that neither the participants nor the researchers know which treatment is being given to maintain objectivity. During the study, participants will be monitored regularly to evaluate their blood sugar levels and overall health. Researchers will track the primary outcome of HbA1c change at 32 weeks and monitor safety throughout the treatment period. Participants will be assessed for any adverse effects, and their adherence to the treatment and lifestyle interventions will be followed closely. The total participation duration includes regular visits and evaluations during the 32-week treatment period.
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
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Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jian Lei
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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