Novo Nordisk brings a new choice for hypoglycemic! Oral semaglutide effect is significant
May 31, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Novo Nordisk announced the results of PIONEER 2, the second phase 3a clinical trial of oral semaglutide. The 52-week open-label study evaluated the efficacy and safety of 14 mg oral semaglutide in 816 patients with type 2 diabetes who were not well controlled with metformin.
Diabetes is a growing global epidemic. As of 2015, 400 million adults worldwide are affected by diabetes, of which about 100 million are in China. People with type 2 diabetes are resistant to insulin or are unable to secrete enough insulin to maintain normal blood sugar levels. Sustained high glucose levels can lead to complications of diabetes such as heart disease, stroke, kidney failure, neuropathy, lower extremity amputation and blindness. Therefore, controlling blood sugar is an urgent goal for patients with type 2 diabetes.
Oral semaglutide is a novel GLP-1 analogue that promises new therapeutic options for patients with type 2 diabetes. In the PIONEER 2 trial, 816 patients were randomized to receive a daily dose of 14 mg orally with semaglutide or 25 mg of empagliflozin. The confirmatory endpoint was glycated hemoglobin (HbA1c) change and body weight change from baseline to week 26. Key secondary endpoints included HbA1c changes and body weight changes from baseline to week 52.
Two different statistical methods were used in this trial to assess the efficacy of oral semaglutide: the main statistical methods were required by recent regulatory guidelines, whether or not to stop treatment and use of first aid drugs; secondary statistical methods described in treatment and not The effect of using emergency medicine.
â–² Novo Nordisk Semruide Injection Ozempic was approved in the United States at the end of last year (Source: NovoCare)
The results of the main statistical methods showed that the trial reached its main goal, demonstrating that oral smeglutide improved HbA1c better at 26 weeks, but there was no significant difference in weight loss compared with the control group.
The results of the secondary statistical method showed that the HbA1c improvement in the oral semaglutide group was 1.4% at 26 weeks and 1.3% at 52 weeks, while the HbA1c improvement in the control group was 0.9% and 0.8%, respectively. At the same time, oral smeglutide showed a weight loss of 4.2 kg and 4.7 kg at 26 and 52 weeks, compared with 3.8 kg in the control group. In addition, 72% of the oral semaglutide group met the American Diabetes Association (ADA) HbA1c treatment target (less than 7.0%) at 52 weeks, compared with 47% in the control group.
In terms of safety, oral semaglutide showed good tolerance in the trial and was consistent with GLP-1 therapy.
â–² Dr. Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk (Source: Novo Nordisk Official Website)
“We are very excited about these results, which shows that patients who are treated with 14 mg of oral smeglutide for one year have significantly lower blood sugar and body weight,†said Dr. Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk. "PIONEER 2 is an important milestone in the clinical development of oral semaglutide, and we look forward to further understanding of the clinical profile of oral smeglutide in the remaining PIONEER trials."
Reference materials:
[1] Oral semaglutide shows superior improvement in HbA1c vs empagliflozin in the PIONEER 2 trial
[2] Novo Nordisk's Oral Diabetes Drug Beats Out Jardiance in Phase III Trial
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