The Comparison of the Effect of Adding Empagliflozin to the Medication Regimen on Peripheral Neuropathy in Patients With Type II Diabetes: A Double Blind Randomised Clinical Trial

Abstract

Introduction: Diabetes is the common metabolic disorder. Empagliflozin is a new medication that acts as a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It promotes increased glucose excretion through urine, which helps improve blood sugar control, enhances glucose metabolism, and reduces glucotoxicity and insulin resistance. This study aimed to investigate and compare the effects of adding empagliflozin to a medication regimen on peripheral neuropathy in diabetes.

Materials and methods: This study involved 50 patients with diabetic neuropathy, confirmed by the Michigan Neuropathy Screening Instrument, who were randomly assigned to two groups. The control group continued their previous medication regimen with a placebo, while the treatment group added 10 mg of empagliflozin daily to their existing regimen. At the start of the study, fasting blood glucose, haemoglobin A1c, serum creatinine levels and electrophysiological findings (including amplitude, latency and nerve conduction velocity) were assessed for all patients. These parameters were re-evaluated at the end of the 20-week intervention, and the results were analysed using statistical software.

Results: At the end of the study, there was a significant reduction in both haemoglobin A1c and fasting blood glucose levels in the treatment group. Serum creatinine levels also significantly decreased. eGFR (estimated glomerular filtration rate) increased in the treatment group. In the Michigan Neuropathy Screening Instrument, the oral test score improved in the treatment group, but no significant difference was observed in the clinical examination scores. Additionally, electrophysiological testing showed a significant improvement in nerve conduction velocity in the treatment group. Latency also decreased in the treatment group, but no significant difference was observed in amplitude between the two groups.

Conclusion: Empagliflozin reduces blood glucose levels and improves kidney filtration function. It also enhances clinical symptoms and nerve conduction velocity in patients with diabetic neuropathy.

Keywords: SGLT2 inhibitors; diabetes mellitus; empagliflozin; peripheral neuropathy.