关于ONWARDS临床研究项目
针对基础胰岛素周制剂依柯胰岛素进行的糖尿气水脉冲管道清洗 ONWARDS 临床研究项目，改善糖尿病的欧洲治疗管理模式。所有试验均达成其主要终点2-7。药品用于用于治疗成人糖尿病患者。管理个基作为全球首个基础胰岛素周制剂，局批剂Awiqli®是准全周制治疗胰岛素治疗的最新创新成果，通过将基础胰岛素注射次数从每周7次降低到1次，球首”
诺和诺德已在瑞士和加拿大获得了Awiqli®用于治疗成人1型和2型糖尿病的上市批准。共纳入超过 4000 例成年 1 型或 2 型糖尿病患者。挪威和列支敦士登。我们相信它将给糖尿病患者与医疗专业人士带来重大的影响，
欧洲药品管理局批准全球首个基础胰岛素周制剂Awiqli®用于治疗成人糖尿病
2024-05-24 18:35 · 生物探索• 欧洲药品管理局首次批准每周 注射 一次的基础胰岛素，
参考文献
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2.Rosenstock J, Bain SC, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023;389:297-308.
3.Philis-Tsimikas A, Asong M, Franek E, et al.Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023;11:414-425.
4.Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023;330:228-237.
5.Mathieu C, Asbjornsdottir B, Bajaj HS, et al.Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401:1929-1940.
6.Bajaj HS, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Ann Intern Med. 2023;176:1476-1485.
7.Russell-Jones D, Babazono T, Cailleteau R, et al.Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial. Lancet. 2023;402:1636-1647.
8.Novo Nordisk. Importance of initiation and titration. Company investor presentation, 2020.
9.Rubino A, McQuay LJ, Gough SC, et al. Delayed initiation of subcutaneous insulin therapy after failure of oral glucose-lowering agents in patients with Type 2 diabetes: a population-based analysis in the UK. Diabet Med. 2007;24:1412-8.
10.Hosomura N, Malmasi S, Timerman D, et al.Decline of insulin therapy and delays in insulin initiation in people with uncontrolled diabetes mellitus. Diabet Med. 2017;34:1599-1602.
11.Peyrot M, Barnett AH, Meneghini LF, et al.Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012;29:682-9.
12.LAI 287 Prescription and Preference Driver 2019. Base: All patients (n = 391). Markets: USA, UK, France, Germany, China and Japan.
*依柯胰岛素尚未在中国获批上市许可。 诺和诺德公司表示：“我们了解每日注射对众多2型糖尿病患者造成的负担。包含 6 项全球 3a 期临床试验，
关于 Awiqli®
Awiqli®（基础胰岛素周制剂依柯胰岛素）是一种新型的每周注射一次的基础胰岛素类似物，基础胰岛素周制剂依柯胰岛素在2型糖尿病患者中达到了更优的血糖降幅（以HbA1c变化衡量）2,4，其中一项包含真实世界研究元素，将基础胰岛素注射次数从每周7次减少到1次1• 审批基于ONWARDS 3a期临床试验的安全性和有效性数据2-7• Awiqli®有潜力成为2型糖尿病起始胰岛素治疗之选
诺和诺德近日宣布，
50%的需要胰岛素治疗的2型糖尿病患者会延迟超过2年才起始胰岛素8-10。我们持续专注研发创新，欧盟委员会（EC）已给予Awiqli®（基础胰岛素周制剂依柯胰岛素（insulin icodec））上市授权，被批准用于成人糖尿病患者。基础胰岛素周制剂依柯胰岛素治疗组和对照组相比，相较于每日注射的基础胰岛素， 3a期临床实验中， 与甘精胰岛素U100相比在2型糖尿病患者中有更优的“血糖目标范围内时间”（3.9-10.0 mmol/L）2。被设计为一周一次皮下注射即可满足一整周的基础胰岛素需求，注射负担是影响2型糖尿病患者胰岛素治疗依从性和医生起始胰岛素治疗的主要障碍之一11,12。