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The efficacy of Empagliflozin on the diabetic peripheral neuropathy

The efficacy of adding Empagliflozin to the medical treatment on the diabetic peripheral neuropathy in type II diabetic patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230919059469N1
Enrollment
50
Registered
2025-09-18
Start date
2023-11-22
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

diabetic peripheral neuropathy. Type 2 diabetes mellitus with diabetic polyneuropathy

Interventions

Intervention 1: Intervention group: Oral empagliflozin 10 mg daily for 20 weeks along with previous medication regimen. Intervention 2: Control group: Oral placebo tablet daily for 20 weeks along with

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: A minimum of 3 years of history with type 2 diabetes, diagnosed by an endocrinologist, with a stable medication regimen for at least the past year HbA1c < 8% Confirmation of Diabetic Neuropathy with Screening Test

Exclusion criteria

Exclusion criteria: History of hereditary neuropathy or other acquired causes of neuropathy such as hypothyroidism Having any vascular disease such as stroke, varicose veins Patients who have had active foot infections Any history of trauma to limbs, deformity, and amputation Patients who have been treated for neuropathy History of neurological and psychiatric disorders such as epilepsy, mood disorder Pregnancy or lactation Smoking Insulin injection Use of hormonal and estrogenic drugs Liver diseases, kidney diseases, retinopathy, nephropathy, and acute or chronic inflammation

Design outcomes

Primary

MeasureTime frame
Michigan Neuropathy Screening Instrument score. Timepoint: Measurement of Michigan Neuropathy Screening Instrument scores at the beginning of the study and 20 weeks after the start of the intervention. Method of measurement: Michigan Neuropathy Screening Instrument questionnaire and clinical examination.

Secondary

MeasureTime frame
Blood gloucose. Timepoint: Measurement of blood gloucose at the beginning of the study and 20 weeks after the start of the intervention. Method of measurement: Patient's blood test.;Blood creatinine. Timepoint: Measurement of blood creatinine at the beginning of the study and 20 weeks after the start of the intervention. Method of measurement: Patient's blood test.;HbA1c. Timepoint: Measurement of HbA1c at the beginning of the study and 20 weeks after the start of the intervention. Method of measurement: Patient's blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Mirzai Malek Abad

Yazd University of Medical Sciences

saber.akbarnia@gmail.com+98 35 9100 3090

Outcome results

None listed

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