Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06589765

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Beijing Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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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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