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.

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) age and time since DPN diagnosis were 62.6 (8.48) and 4.89 (5.662) years, respectively. The least-squares mean (LSM) change in mTCNS sum scores for numbness and tingling at 12 weeks was -1.0 in both groups (LSM difference: 0.0; 95% confidence interval -0.4 to 0.4). The LSM changes in the mTCNS total scores were -2.6 (0.64) and -2.3 (0.67) in the ONO-2910 and placebo groups, respectively. There were no marked changes in nerve function and nerve conduction velocities in the ONO-2910 and placebo groups. Treatment-emergent adverse events (TEAEs) occurred in 37 (48.1%) and 39 (50.6%) patients in the ONO-2910 and placebo groups, respectively. TEAEs in ≥2 patients in the ONO-2910 group were nasopharyngitis (5 patients), diarrhea (3 patients), nausea (2 patients), and eczema (2 patients).

CONCLUSIONS

ONO-2910 was generally well-tolerated in Japanese patients with DPN. There were no obvious improvements in DPN symptoms or neurosensory function among patients who received ONO-2910 versus placebo.

CLINICAL TRIAL REGISTRY: Japan Primary Registries Network jRCT2061210008.