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CompletedNCT06589765Updated Jun 30, 2026

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

A Phase 3 interventional study of HRS-7535 tablet and dapagliflozin tablet in Type 2 Diabetes, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
810
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 810 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
810 participants (actual)

Study arms

  • Experimental
    Treatment group A

    subjects will receive HRS-7535 tablet orally at dose 1.

    Drug: HRS-7535 tablet

  • Experimental
    Treatment group B

    subjects will receive HRS-7535 tablet orally at dose 2.

    Drug: HRS-7535 tablet

  • Experimental
    Treatment group C

    subjects will receive HRS-7535 tablet orally at dose 3.

    Drug: HRS-7535 tablet

  • Active comparator
    Treatment group D

    subjects will receive dapagliflozin tablet orally.

    Drug: dapagliflozin tablet

Interventions

  • DrugHRS-7535 tablet

    HRS-7535 tablet

  • Drugdapagliflozin tablet

    dapagliflozin tablet

06

What researchers measure

Primary outcomes

  1. Change from baseline in HbA1c at 32 weeks of treatment

    Time frame: at 32 weeks

Secondary outcomes

  1. Percentage of Participants Who Achieved HbA1c <7.0% at Week 32

    Time frame: at 32 weeks

  2. Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32

    Time frame: at 32 weeks

  3. Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32

    Time frame: at 32 weeks

  4. Percentage Change from Baseline in Body Weight, from Baseline to Week 32

    Time frame: at 32 weeks

  5. Change from Baseline in Body Weight, from Baseline to Week 32

    Time frame: at 32 weeks

  6. Change from Baseline in Waist Circumference, from Baseline to Week 32

    Time frame: at 32 weeks

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing Municipality 100730, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589765
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 27, 2024
Primary completion
May 29, 2026
Completion
May 29, 2026
Last update
Jun 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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