{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T02:26:51Z","timestamp":1793759211088,"version":"4.6.1"},"reference-count":43,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Crisugabalin (HSK16149), a selective \u03b3\u2010aminobutyric 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>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\u2009mg\/day) or pregabalin (300\u2009mg\/day) for 4\u2009weeks. The primary endpoint was the mean change of SF\u2010MPQ pain score from baseline to 4\u2009weeks of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Ninety\u2010three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9\u2009years; 49 men). The least square mean (LSM) difference in the mean change of SF\u2010MPQ pain score was \u22127.2 (95% CI: \u221212.4, \u22122.0; ANCOVA\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.007) between the two groups. The rate of treatment\u2010emergent adverse events was 29.5% (13\/44) and 47.8% (22\/46) in the crisugabalin and pregabalin groups, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Treatment with crisugabalin 40\u2009mg\/day resulted in greater pain reduction in comparison to pregabalin 300\u2009mg\/day over a period of 4\u2009weeks in DPNP patients with inadequate response to prior pregabalin treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71401","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:17:33Z","timestamp":1790929053000},"page":"11946-11954","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active\u2010Controlled, Phase 2 Trial"],"prefix":"10.1111","volume":"28","author":[{"given":"Yaming","family":"Li","sequence":"first","affiliation":[{"name":"Shaanxi Key Laboratory of Natural Products &amp; Chemical Biology College of Chemistry &amp; Pharmacy, Northwest A&amp;F University  Xianyang Shaanxi Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Kaifeng Hospital of Traditional Chinese Medicine  Kaifeng Henan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Yongzhou Central Hospital  Yongzhou Hunan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiuhai","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Cangzhou Integrated Traditional Chinese and Western Medicine Hospital  Cangzhou Hebei Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Shaoyang Central Hospital  Shaoyang Hunan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Nanyang Central Hospital  Nanyang Henan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junjie","family":"Shang","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Nanyang Second People's Hospital  Nanyang Henan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Suzhou Ninth People's Hospital  Suzhou Jiangsu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liujun","family":"Fu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology The First Affiliated Hospital of Henan University of Science and Technology  Luoyang Henan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangqiong","family":"Li","sequence":"additional","affiliation":[{"name":"Haisco Pharmaceutical Group Co., Ltd.  Chengdu Sichuan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Endocrinology The Second Affiliated Hospital of Zhejiang University School of Medicine  Hangzhou Zhejiang Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2992-0527","authenticated-orcid":false,"given":"Jinyou","family":"Duan","sequence":"additional","affiliation":[{"name":"Shaanxi Key Laboratory of Natural Products &amp; Chemical Biology College of Chemistry &amp; Pharmacy, Northwest A&amp;F University  Xianyang Shaanxi Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,2]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01301-6"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/1753-0407.70012"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(24)00038-3"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-024-01041-y"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41574-021-00496-z"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awab079"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2018.04.001"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(12)70065-0"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2025.107789"},{"key":"e_1_2_9_11_1","first-page":"583594","article-title":"Evidence\u2010Based Treatment of Painful Diabetic Neuropathy: A Systematic Review","volume":"26","author":"D'Souza R. S.","year":"2022","journal-title":"Current Pain and Headache Reports"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2024.116417"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)01472-6"},{"key":"e_1_2_9_14_1","article-title":"Pregabalin for Neuropathic Pain in Adults","volume":"1","author":"Derry S.","year":"2019","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2006.04.022"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0409066103"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.120.000315"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.117.247551"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pbb.2025.174015"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.21-16-06095.2001"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M308778200"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.25614"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2024.3410"},{"key":"e_1_2_9_24_1","volume-title":"Definition, Diagnosis and Classification of Diabetes Mellitus and Its Complications: Report of a WHO Consultation. Part 1: Diagnosis and Classification of Diabetes Mellitus","author":"WHO","year":"1999"},{"issue":"8","key":"e_1_2_9_25_1","first-page":"561","article-title":"Chinese Expert Consensus on Diagnosis and Treatment of Diabetic Peripheral Neuropathy","volume":"24","author":"Pain and Sensory Disorders Committee of the Neurology Branch of the Chinese Medical Doctor Association","year":"2018","journal-title":"Chinese Journal of Pain Medicine"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2007.09.016"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S116997"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2016.11.016"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S442595"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1103"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejp.1989"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40122-021-00255-y"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.22603\/ssrr.1.2016-0012"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2023.1296672"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737175.2019.1653760"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2009.09.017"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40122-021-00281-w"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.35632"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000001439"},{"key":"e_1_2_9_40_1","first-page":"4190","article-title":"Risk Factors and Pain Status due to Diabetic Neuropathy in Chronic Long\u2010Term Diabetic Patients in a Chinese Urban Population","volume":"125","author":"Ji N.","year":"2012","journal-title":"Chinese Medical Journal"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40122-024-00617-2"},{"key":"e_1_2_9_42_1","volume-title":"LYRICA (Pregabalin) Prescribing Information","author":"Viatris","year":"2025"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-023-00681-y"},{"key":"e_1_2_9_44_1","unstructured":"ClinicalTrials.gov \u201cTo Evaluate the Long\u2010Term Safety and Efficacy of hsk16149 in Chinese Patients With Peripheral Neuralgia\u201dClinicalTrials.gov identifier: NCT05890053 updated May 24 2023 accessed December 28 2024 https:\/\/clinicaltrials.gov\/study\/NCT05890053."}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dom-pubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.71401","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.71401","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.71401","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T02:00:41Z","timestamp":1793757641000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.onlinelibrary.wiley.com\/doi\/10.1111\/dom.71401"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,2]]},"references-count":43,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2026,12]]}},"alternative-id":["10.1111\/dom.71401"],"URL":"https:\/\/doi.org\/10.1111\/dom.71401","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.71401\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.71401\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.71401\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.71401\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.71401\/v2\/response1","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,2]]},"assertion":[{"value":"2026-07-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-18","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}