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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: dapagliflozin tablet; Drug: HRS-7535 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06589765

HRS-7535-302

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

800 participants in 4 patient groups

Treatment group A

Experimental group

Description:

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

Treatment:

Drug: HRS-7535 tablet

Treatment group B

Experimental group

Description:

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

Treatment:

Drug: HRS-7535 tablet

Treatment group C

Experimental group

Description:

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

Treatment:

Drug: HRS-7535 tablet

Treatment group D

Active Comparator group

Description:

subjects will receive dapagliflozin tablet orally.

Treatment:

Drug: dapagliflozin tablet