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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HRS-7535 tablet; Drug: dapagliflozin tablet

• Registration Number: NCT06589765
• Lead 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-09-27
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-02-18
• Study Completion: 2026-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	HRS-7535 tablet	subjects will receive HRS-7535 tablet orally at dose 1.
Treatment group B	HRS-7535 tablet	subjects will receive HRS-7535 tablet orally at dose 2.
Treatment group C	HRS-7535 tablet	subjects will receive HRS-7535 tablet orally at dose 3.
Treatment group D	dapagliflozin tablet	subjects will receive dapagliflozin tablet orally.

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 32 weeks of treatment	at 32 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China