Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor on Urinary Protein

Peking University

Status: Enrolling

Conditions: Antidiabetic Drugs; Type 2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT05922852

M2023228

Details and patient eligibility

About

The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

Full description

This project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18 years
• Clinical diagnosis of type 2 diabetes mellitus
• Immediate urine albumin creatinine ratio greater than 30mg/g
• Signed informed consent and available for follow-up

Exclusion criteria

• severe renal insufficiency, i.e. eGFR ≤ 30ml/min/1.75m2
• clinical diagnosis of various acute and chronic urinary tract infections
• combined with various serious infectious diseases
• combined with acute complications of diabetes mellitus
• end-stage malignancy
• pregnancy and lactation

Trial design

1,000 participants in 4 patient groups

SGLT2i+ARNI

Description:

patients in this group received SGLT2i combined with ARNI medication。

SGLT2i only

Description:

patients in this group received SGLT2i medication only。

ARNI only

Description:

patients in this group received ARNI medication only。

control

Description:

patients in this group received neither SGLT2i nor ARNI。