Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

Phase 3 Completed 500 enrolled Sumitomo Pharma Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.

Timeline

Start: 2004-10
Primary completion: —
Completion: 2006-09

Outcome

Met primary endpoint

release “a significant increase in summed nerve conduction velocity as the primary endpoint was seen in all ranirestat arms compared to before administration.” sumitomo-pharma.com ↗

Publications

Bril V, Hirose T, Tomioka S, Buchanan R; Ranirestat Study Group. Ranirestat for the management of diabetic sensorimotor polyneuropathy. Diabetes Care. 2009 Jul;32(7):1256-60. doi: 10.2337/dc08-2110. Epub 2009 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranirestat	Small molecule	10 mg	—
Subject	Ranirestat	Small molecule	20 mg	—
Subject	Ranirestat	Small molecule	40 mg	—