Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
研究概览
简要总结
The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin.
- •Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.
排除标准
- •Breastfeeding female.
- •Pregnant female.
- •Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m
- •Patients with type 1 diabetes mellitus.
- •Patients with diabetic ketoacidosis.
- •Patients with urinary tract infections.
- •Dehydrated patients till normalized.
- •Lower limb amputation patients.
- •SGLT2 inhibitors hypersensitivity.
- •Severe hepatic patients.
- •Patients on neuroprotective drugs.
研究组 & 干预措施
Empagliflozin group
include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
时间窗: change from baseline at three month
The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups.
Change in HbA1c %
时间窗: change from baseline at three months
HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.
次要结局
未报告次要终点
研究者
Maha Khalifa
Principal Investigator
Tanta University