An exploratory clinical study of the renoprotective effect of empagliflozin and the verification of companion diagnostics in type 2 diabetes patients

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000023902
• Lead Sponsor: Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

1) Those with past histories of hypersensitivity to SGLT2 inhibitors 2) Those with severe ketosis, diabetic coma or precoma 3) Those at perioperative stages, or those with severe infection or serious injury 4) Those with followings: 1. Hypopituitarism or adrenal insufficiency 2. Malnutrition, starvation, irregular or insufficient food intake, or debilitating condition 3. Excessive muscular exercise 4. Excessive alcohol drinker 5 ) Those with urinary tract or genital infection 6) Those with severe liver dysfunction 7) Those who are pregnant or hoping pregnancy 8) Those with a malignant tumor currently or in the past 5 years 9) Those who are treated currently with SGLT2 inhibitors 10) Those who are considered not eligible for the study by attending doctors because of any medical reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the association between the concentration of urinary megalin and its ligand molecules such as alpha1-microglobulin and beta2-microglobulin and the change in renal function (eGFR)

Secondary Outcome Measures

Name	Time	Method
1) The change in eGFR 2) Notable adverse effects (hypoglycemia, urinary tract, and genital infection, etc) 3) Serious adverse events (serious hypoglycemia, sepsis, hypovolemia, cerebral infarction, ischemic heart disease, ketoacidosis, acute kidney injury, and serious eruption, etc) 4) Other biomarkers such as urinary podocalyxin 5) Dietary evaluation using self-administered diet history questionnaire (DHQ) 6) Ambulatory blood pressure monitoring (ABPM)