{
  "abstract": "Aims: Crisugabalin (HSK16149), a selective γ‐aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown.\n\nMaterials and Methods: This multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF‐MPQ pain score from baseline to 4 weeks of treatment.\n\nResults: Ninety‐three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF‐MPQ pain score was −7.2 (95% CI: −12.4, −2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment‐emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively.\n\nConclusions: Treatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.",
  "abstract_shown": true,
  "affiliations": [
    "Shaanxi Key Laboratory of Natural Products & Chemical Biology College of Chemistry & Pharmacy, Northwest A&F University Xianyang Shaanxi Province China",
    "Department of Endocrinology Kaifeng Hospital of Traditional Chinese Medicine Kaifeng Henan Province China",
    "Department of Endocrinology Yongzhou Central Hospital Yongzhou Hunan Province China",
    "Department of Endocrinology Cangzhou Integrated Traditional Chinese and Western Medicine Hospital Cangzhou Hebei Province China",
    "Department of Endocrinology Shaoyang Central Hospital Shaoyang Hunan Province China",
    "Department of Endocrinology Nanyang Central Hospital Nanyang Henan Province China",
    "Department of Endocrinology Nanyang Second People's Hospital Nanyang Henan Province China",
    "Department of Endocrinology Suzhou Ninth People's Hospital Suzhou Jiangsu Province China",
    "Department of Endocrinology The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Province China",
    "Haisco Pharmaceutical Group Co., Ltd. Chengdu Sichuan Province China",
    "Department of Endocrinology The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Province China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Yaming Li"
    },
    {
      "affs": [
        1
      ],
      "name": "Fang Zhang"
    },
    {
      "affs": [
        2
      ],
      "name": "Wei Liu"
    },
    {
      "affs": [
        3
      ],
      "name": "Xiuhai Su"
    },
    {
      "affs": [
        4
      ],
      "name": "Bin Zhou"
    },
    {
      "affs": [
        5
      ],
      "name": "Na Xu"
    },
    {
      "affs": [
        6
      ],
      "name": "Junjie Shang"
    },
    {
      "affs": [
        7
      ],
      "name": "Chen Fang"
    },
    {
      "affs": [
        8
      ],
      "name": "Liujun Fu"
    },
    {
      "affs": [
        9
      ],
      "name": "Fangqiong Li"
    },
    {
      "affs": [
        10
      ],
      "name": "Chao Zheng"
    },
    {
      "affs": [
        0
      ],
      "name": "Jinyou Duan",
      "orcid": "0000-0002-2992-0527"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/8dkn19q33braa.bib",
  "cited_by": 1,
  "doi": "10.1111/dom.71401",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13731062/",
  "id": "8dkn19q33braa",
  "issns": [
    "1462-8902",
    "1463-1326"
  ],
  "landing_url": "https://doi.org/10.1111/dom.71401",
  "language": "en",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Article"
    ],
    [
      "openalex",
      "2737|Pain Mechanisms and Treatments"
    ]
  ],
  "openalex": "W7215828320",
  "pdf_url": "https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.71401",
  "pmcid": "PMC13731062",
  "pmid": "42823911",
  "published": "2026-10-02",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/8dkn19q33braa.ris",
  "sources": [
    {
      "first_seen": "2026-11-08T12:21:19Z",
      "native_id": "PMC13731062",
      "source": "pmc",
      "url": "https://doi.org/10.1111/dom.71401"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2737|Pain Mechanisms and Treatments",
      "subfield": "physiology"
    }
  ],
  "title": "Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial",
  "title_text": "Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:21:19Z",
  "url": "https://research.draconitic.com/paper/8dkn19q33braa",
  "venue": "Diabetes, Obesity & Metabolism",
  "versions": []
}