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Novo Nordisk (NVO) Monday announced positive results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide in inadequately controlled type 2 diabetes. The company said the trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.COMBINE 3 was a 52-week, open-label treat-to-target trial of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart, dosed with or without oral glucose-lowering medications, in 679 people.The study showed that an overall baseline HbA1c of 8.30, once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart..
诺和诺德(Novo Nordisk)周一宣布,每周一次的IcoSema联合3期3a试验取得了积极结果,IcoSema是基础胰岛素icodec和semaglutide的固定比例组合,用于治疗控制不佳的2型糖尿病。该公司表示,该试验的主要终点是,与甘精胰岛素U100和门冬胰岛素相比,每周一次的IcoSema在第52周降低HbA1c方面表现出非劣效性。COMBINE 3是一项为期52周的开放标签治疗靶向试验,对679人进行了每周一次的IcoSema与每日一次的甘精胰岛素U100和门冬胰岛素的对比试验,服用或不服用口服降糖药物。该研究表明,每周一次的IcoSema的总体基线HbA1c为8.30,估计HbA1c降低了-1.47个百分点,而甘精胰岛素U100和门冬胰岛素的HbA1c降低了-1.40个百分点。。
The trial also revealed a weight reduction of -3.6 kg, from a baseline body weight of 85.8 kg, with IcoSema and a weight gain of 3.2 kg with insulin glargine U100 and insulin aspart.Once-weekly IcoSema appeared to have a safe and well-tolerated profile, the company noted. For comments and feedback contact: editorial@rttnews.comBusiness News.
该试验还显示,使用IcoSema后,基线体重为85.8公斤,体重减轻了-3.6公斤,使用甘精胰岛素U100和门冬胰岛素后,体重增加了3.2公斤。该公司指出,每周一次的IcoSema似乎有一个安全且耐受性良好的概况。如需评论和反馈,请联系:editorial@rttnews.comBusiness新闻。
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