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Screenshot Source: CDE.com According to a recent interview with Professor Tang Mei, Executive Vice President and Chief Scientific Officer of Novo Nordiak Global, the CDE's content team is pushing icodec insulin to go on sale in China in tandads with the world.
, the drug in the study is currently in the process of conducting a global Phase 3 clinical trial.
, China is also about to join the global Phase 3 clinical trials.
this long-acting insulin means a lot to diabetics.
We know that many people with type 2 diabetes who require insulin treatment tend to be injected at least once a day, more often 2-4 times, and may need to combine oral medications, which means complex treatment strategies and self-blood sugar management.
, Scientists at Noor and Nord developed icodec by modifying insulin molecules.
injection, icodec binds firmly and reversiblely to albumin, creating a "circular repository" with a half-life of up to 196 hours.
allows the candidate to release insulin consistently and steadily, meeting the patient's basic insulin needs for a full week.
icodec injection dose is equivalent to a daily insulin glycelin U100 injection for a week, thanks to a concentrated formula.
the results of phase 2 clinical trials of icodec insulin at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD) 2020.
154 patients took part in the 16-week trial, which involved adults with type 2 diabetes who had taken oral anti-diabetic drugs but had poor symptom control.
results showed good efficacy and tolerance compared to a daily injection of insulin glycerion U100.
patients who were given one or two basic insulin injections a day to icodec insulin once a week did not increase the risk of severe hypoglycemia.
At the same time, the proportion of patients receiving icodec insulin therapy using the load dose administration method (increasing the dosage at the first dose and increasing the concentration of the drug in the body more rapidly to steady-state levels) was 73%, significantly higher than that of the insulin U100 group (65%).
another phase of clinical trials published in the New England Journal of Medicine showed that the effect and safety of using icodec insulin in adults with type 2 diabetes who had not been treated with insulin was similar to that of patients who received insulin glycelin U100 once a day.
screenshot Source: New England Journal of Medicine Website Reference: China's National Drug Administration Drug Review Center. Retrieved Nov 26, 2020, from the Phase 2 clinical trial has shown the efficacy and toerability of icodec. Retrieved September 24, 2020, from Source: Medical Mission Hills