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

NCT06589765 | Recruiting Phase 3

• 1 other identifier: HRS-7535-302
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at 32 weeks of treatment

  at 32 weeks

Secondary Outcomes (6)

• 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

Study Arms (4)

Treatment group A

EXPERIMENTAL

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

Drug: HRS-7535 tablet

Treatment group B

EXPERIMENTAL

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

Drug: HRS-7535 tablet

Treatment group C

EXPERIMENTAL

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

Drug: HRS-7535 tablet

Treatment group D

ACTIVE COMPARATOR

subjects will receive dapagliflozin tablet orally.

Drug: dapagliflozin tablet

Interventions

HRS-7535 tablet DRUG

HRS-7535 tablet

Treatment group A; Treatment group B; Treatment group C

dapagliflozin tablet DRUG

dapagliflozin tablet

Treatment group D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-75 age years, both inclusive;
• Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
• HbA1c 7.5-11.0% (both inclusive) at screening;
• Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.

You may not qualify if:

• Known or suspected allergy to the investigational drug or its components or excipients.
• Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
• Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
• Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
• Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jian Lei

CONTACT

00-86-518-82342973; jian.lei.jl9@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-7535 tablet compared with dapagliflozin tablet

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion: February 18, 2026
• Study Completion (Estimated): July 18, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-09

Locations

CN (1)