Evaluation of the effectiveness and safety of ONO-2910 for the treatment of diabetic polyneuropathy: An early Phase IIa, multicenter, randomized, placebo-controlled, double-blind study in Japanese patients.

ABSTRACT:

Aims/introduction

Diabetic polyneuropathy (DPN) is common in patients with diabetes. Its symptoms include pain, numbness, and impaired neurosensory function. ONO-2910 promotes Schwann cell differentiation and is being developed for DPN.

Materials and methods

This Phase IIa randomized controlled trial evaluated the effectiveness and safety of ONO-2910 in Japanese patients with type 2 diabetes and DPN. Patients were randomized to ONO-2910 (300 mg/day) or placebo, once daily, for 12 weeks. The primary endpoints were the changes in the sum scores for numbness and tingling (modified Toronto Clinical Neuropathy Scores [mTCNS]) and safety.

Results

The ONO-2910 and placebo groups comprised 76 (safety: 77 patients) and 77 patients, respectively. The mean (standard deviation) a

SUBMITTER: Onishi Y 

PROVIDER: S-EPMC12862990 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature