Diabetic Polyneuropathy
Conditions
Interventions
Epalrestat, 150mg/day, 3 years
Control
Sponsors
Aichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Correspond to all of the following in recruitment of participants with type 2 diabetes: 1. HbA1c <= 9.0% 2. Diabetes treatment including diet therapy, exercise therapy, medication, and insulin therapy 3. Patients who meets more than 2 of 3 below: i) Bilateral neuropathic symptom of lower extremities ii) Bilateral decreased vibration sensation of lower extremities iii) Bilateral decrease or absence of Achilles tendon reflexes.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation 2. Type 1 diabetes, othertypes of diabetes 3. Past history of diabetic ketoacidosis 4. Severe infection, Pre-/post-operation, Severe injuries 5. Treatment with steroids 6. Current/Past malignancy 7. Inappropriate patients for entry on this study in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from screening in corneal confocal microscopic findings at month 36 2. Change from screening in nerve conduction studies at month 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Score of Michigan Neuropathy Screening Instrument(MNSI) 2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation 3. HbA1c, blood glucose 4. Coefficients of variance of RR intervals 5. Diabetic nephropathy, Diabetic retinopathy 6. Laboratory data, blood pressure 7. safety | — |
Countries
Japan
Contacts
Public ContactHideki Kamiya
Aichi Medical University Diabetes
Outcome results
None listed