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NCT05922852 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
the Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor Over Monotherapy on Urinary Protein in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05922852
Other study ID # M2023228
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date February 28, 2024

Study information
Verified date April 2023
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University Third Hospital Beijing Beijing
China Peking University Third Hospital, Beijing, Beijing 100191 Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary protein changes 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. 2023.03-2024.03
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