A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
NCT ID: NCT06589765
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2024-09-27
2026-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group A
subjects will receive HRS-7535 tablet orally at dose 1.
HRS-7535 tablet
HRS-7535 tablet
Treatment group B
subjects will receive HRS-7535 tablet orally at dose 2.
HRS-7535 tablet
HRS-7535 tablet
Treatment group C
subjects will receive HRS-7535 tablet orally at dose 3.
HRS-7535 tablet
HRS-7535 tablet
Treatment group D
subjects will receive dapagliflozin tablet orally.
dapagliflozin tablet
dapagliflozin tablet
Interventions
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HRS-7535 tablet
HRS-7535 tablet
dapagliflozin tablet
dapagliflozin tablet
Eligibility Criteria
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Inclusion Criteria
2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
3. HbA1c 7.5-11.0% (both inclusive) at screening;
4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
Exclusion Criteria
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
18 Years
75 Years
ALL
No
Sponsors
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Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-7535-302
Identifier Type: -
Identifier Source: org_study_id
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