Effect of Empagliflozin in diabetic nephropathy

Assessment of Empagliflozin effect on renal outcome in patients with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210906052395N1

Enrollment

Registered

2022-03-16

Start date

2021-09-23

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy and proteinuria in diabetic nephropathy patients taking empagliflozin. Diabetes mellitus due to underlying condition with diabetic nephropathy

Interventions

Intervention 1: Intervention group: Receive 10 mg Empagliflozin tablets (Gloripa brand, Abidi Pharmaceutical Company,) one daily for 48 weeks in addition to the previous standard treatment(metformin a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient with type2 diabetes over the age of 18 years GFR<60 or albuminuria

Exclusion criteria

Exclusion criteria: Recent myocatdial infarction and PCI Dialysis in the last ninety days GFR<30 Renal failure for reasons other than diabetes Recurrent urinary tract infections History of amputation due to diabetes Bladder cancer Active diabetic foot ulcer type 1 diabetes Pregnancy and lactation Major surgery performed in the last 28 days

Design outcomes

Primary

Measure	Time frame
Body mass index(BMI). Timepoint: Weeks 0-12-24-48. Method of measurement: Weight in kilograms divided by height squared in meters.;Evaluation of glycated hemoglobin or long-term blood sugar. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Fasting blood sugar measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of glomerular filtration level for indirect evaluation of kidney status. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of urinary albumin / creatinine ratio. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Plasma creatinine measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of urine albumin concentration. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Systolic and diastolic blood pressure. Timepoint: Weeks 0-12-24-48. Method of measurement: Barometer.;Duration of diabetes. Timepoint: Week 0. Method of measurement: Using questionnaire.;Evaluation of aspartate aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Evaluation of alanine aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood alkaline phosphatase level for evaluation of hepatic function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood triglyceride levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Patient quality of life. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire.;Measurement of blood cholesterol levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood LDL levels. Timepoint: Weeks 0-12-24-48. Method of measuremen	—

Measure

Time frame

Body mass index(BMI). Timepoint: Weeks 0-12-24-48. Method of measurement: Weight in kilograms divided by height squared in meters.;Evaluation of glycated hemoglobin or long-term blood sugar. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Fasting blood sugar measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of glomerular filtration level for indirect evaluation of kidney status. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of urinary albumin / creatinine ratio. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Plasma creatinine measurement. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of urine albumin concentration. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Systolic and diastolic blood pressure. Timepoint: Weeks 0-12-24-48. Method of measurement: Barometer.;Duration of diabetes. Timepoint: Week 0. Method of measurement: Using questionnaire.;Evaluation of aspartate aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Evaluation of alanine aminotransferase level for evaluation of liver function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood alkaline phosphatase level for evaluation of hepatic function. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood triglyceride levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Patient quality of life. Timepoint: Weeks 0-12-24-48. Method of measurement: Using questionnaire.;Measurement of blood cholesterol levels. Timepoint: Weeks 0-12-24-48. Method of measurement: Using the laboratory kit.;Measurement of blood LDL levels. Timepoint: Weeks 0-12-24-48. Method of measuremen

—

Secondary

Measure	Time frame
Lower limb edema. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire.;Complications and cardiac events. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire.;Incident of brain stroke. Timepoint: Weeks 0-12-24-48. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlmas khatami zenozian

Shahid Beheshti University of Medical Sciences

Almaskhatami@gmail.com+98 21 7343 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026