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

January 8, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A
subjects will receive HRS-7535 tablet orally at dose 1.
Drug: HRS-7535 tablet
HRS-7535 tablet
Experimental: Treatment group B
subjects will receive HRS-7535 tablet orally at dose 2.
Drug: HRS-7535 tablet
HRS-7535 tablet
Experimental: Treatment group C
subjects will receive HRS-7535 tablet orally at dose 3.
Drug: HRS-7535 tablet
HRS-7535 tablet
Active Comparator: Treatment group D
subjects will receive dapagliflozin tablet orally.
Drug: dapagliflozin tablet
dapagliflozin tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c at 32 weeks of treatment
Time Frame: at 32 weeks
at 32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
Time Frame: at 32 weeks
at 32 weeks
Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
Time Frame: at 32 weeks
at 32 weeks
Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
Time Frame: at 32 weeks
at 32 weeks
Percentage Change from Baseline in Body Weight, from Baseline to Week 32
Time Frame: at 32 weeks
at 32 weeks
Change from Baseline in Body Weight, from Baseline to Week 32
Time Frame: at 32 weeks
at 32 weeks
Change from Baseline in Waist Circumference, from Baseline to Week 32
Time Frame: at 32 weeks
at 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

February 18, 2026

Study Completion (Estimated)

July 18, 2026

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-7535-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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