Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy

Michael Polydefkis, Joseph C. Arezzo, Marshall Nash, Vera Bril, Aziz Shaibani, Robert J. Gordon, Kate L. Bradshaw, Roderick W J Junor

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy (DSPN). Patients (18-75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double-blind, phase II/III study (ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1: 1: 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265: 264: 271). Change in peroneal motor nerve conduction velocity (PMNCV) from baseline to 24 months was the primary endpoint with a goal improvement vs. placebo ≥1.2 m/s. Other endpoints included symptoms, quality-of-life, and safety. Six hundred thirty-three patients completed the study. The PMNCV difference from placebo was significant at 6, 12, and 18 months in both ranirestat groups, but

Original languageEnglish (US)
Pages (from-to)363-371
Number of pages9
JournalJournal of the Peripheral Nervous System
Volume20
Issue number4
DOIs
StatePublished - Dec 1 2015

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Diabetic Neuropathies
Safety
Peroneal Nerve
Neural Conduction
Placebos
Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus
Quality of Life
ranirestat

Keywords

  • aldose reductase
  • clinical trial
  • diabetic neuropathy
  • neuropathy progression

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. / Polydefkis, Michael; Arezzo, Joseph C.; Nash, Marshall; Bril, Vera; Shaibani, Aziz; Gordon, Robert J.; Bradshaw, Kate L.; Junor, Roderick W J.

In: Journal of the Peripheral Nervous System, Vol. 20, No. 4, 01.12.2015, p. 363-371.

Research output: Contribution to journalArticle

Polydefkis, Michael ; Arezzo, Joseph C. ; Nash, Marshall ; Bril, Vera ; Shaibani, Aziz ; Gordon, Robert J. ; Bradshaw, Kate L. ; Junor, Roderick W J. / Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. In: Journal of the Peripheral Nervous System. 2015 ; Vol. 20, No. 4. pp. 363-371.
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