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

Last updated: January 8, 2025
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

HRS-7535 tablet

dapagliflozin tablet

Clinical Study ID

NCT06589765
HRS-7535-302
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Known or suspected allergy to the investigational drug or its components orexcipients.

  2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes orsecondary diabetes.

  3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lacticacidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior toscreening.

  4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic footulcer or intermittent claudication requiring acute treatment;

  5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or womenof childbearing potential (WOCBP) or male subject not using adequate contraceptivemeasures.

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: HRS-7535 tablet
Phase: 3
Study Start date:
September 27, 2024
Estimated Completion Date:
July 18, 2026

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.