Evaluation of the effectiveness and safety of <scp>ONO</scp> ‐2910 for the treatment of diabetic polyneuropathy: An early Phase <scp>IIa</scp> , multicenter, randomized, placebo‐controlled, double‐blind study in Japanese patients
Bibliographic record
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) 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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".