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

June 20, 2023 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital, Beijing, Beijing 100191
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with type 2 diabetes mellitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SGLT2i+ARNI
patients in this group received SGLT2i combined with ARNI medication。
SGLT2i only
patients in this group received SGLT2i medication only。
ARNI only
patients in this group received ARNI medication only。
control
patients in this group received neither SGLT2i nor ARNI。

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary protein changes
Time Frame: 2023.03-2024.03
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2023228

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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