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Journal of Diabetes Research
Volume 2016, Article ID 5383797, 8 pages
http://dx.doi.org/10.1155/2016/5383797
Clinical Study

Effect of Ranirestat on Sensory and Motor Nerve Function in Japanese Patients with Diabetic Polyneuropathy: A Randomized Double-Blind Placebo-Controlled Study

1NTT-EAST Tohoku Hospital, 2-29-1 Yamato-machi, Wakabayashi-ku, Sendai, Miyagi 984-8560, Japan
2Department of Neurology, Kobe City Medical Center General Hospital, 4-6 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan
3Division of Neurology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
4Sumitomo Dainippon Pharma, Co., Ltd., 6-8 Doshomachi 2-chome, Chuo-ku, Osaka 541-0045, Japan

Received 31 August 2015; Revised 2 November 2015; Accepted 17 December 2015

Academic Editor: Rodica Pop-Busui

Copyright © 2016 Jo Satoh et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We conducted a 26-week oral-administration study of ranirestat (an aldose reductase inhibitor) at a once-daily dose of 20 mg to evaluate its efficacy and safety in Japanese patients with diabetic polyneuropathy (DPN). The primary endpoint was summed change in sensory nerve conduction velocity (NCV) for the bilateral sural and proximal median sensory nerves. The sensory NCV was significantly () improved by ranirestat. On clinical symptoms evaluated with the use of modified Toronto Clinical Neuropathy Score (mTCNS), obvious efficacy was not found in total score. However, improvement in the sensory test domain of the mTCNS was significant () in a subgroup of patients diagnosed with neuropathy according to the TCNS severity classification. No clinically significant effects on safety parameters including hepatic and renal functions were observed. Our results indicate that ranirestat is effective on DPN (Japic CTI-121994).