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NCT06589765 | RECRUITING | Type 2 Diabetes

A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Sponsor:

Shandong Suncadia Medicine Co., Ltd.

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.

Condition or disease

Type 2 Diabetes

Intervention/treatment

HRS-7535 tablet

dapagliflozin tablet

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 800 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
Actual Study Start Date : 2024-09-27
Estimated Primary Completion Date : 2026-02-18
Estimated Study Completion Date : 2026-07-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male or female, 18-75 age years, both inclusive;
  • 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
  • 1. Known or suspected allergy to the investigational drug or its components or excipients.
  • 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.
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

Location Details

NCT06589765

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How to Participate

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Locations

RECRUITING

China, Beijing

Beijing Hospital

Beijing, Beijing, China, 100730