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Switching to investigational once-weekly insulin icodec from other basal insulins demonstrated to be efficacious and well-tolerated for people with type 2 diabetes in phase 2 trial

September 22, 2020 08:46 ET

| Source: Novo Nordisk A/S

Bagsværd, Denmark, 22 September 2020 – Today, Novo Nordisk announced results from three phase 2 clinical trials for insulin icodec, an investigational once-weekly basal insulin analogue, which were presented during the 56th European Association for the Study of Diabetes (EASD) Annual Meeting 2020. The first showed that switching to insulin icodec from other basal insulins using two different switch approaches was efficacious and well-tolerated compared to once-daily insulin glargine U100 and the switching approaches were without an increased risk of clinically significant or severe hypoglycaemic episodes compared to once-daily insulin glargine U100.1 This 16-week phase 2 clinical trial involved 154 adults with type 2 diabetes inadequately controlled with oral antidiabetic drugs and once/twice-daily basal insulin  randomised to once-weekly insulin icodec with or without a loading dose or insulin glargine U100.1,2 The primary endpoint of the trial, the blood sugar ‘time in range’ 3.9–10.0 mmol/L during weeks 15 and 16, showed that people receiving insulin icodec with a loading dose demonstrated a significantly greater ‘time in range’ compared to insulin glargine U100 (73% vs 65%, respectively). People who received insulin icodec without a loading dose demonstrated similar blood sugar ‘time in range’ compared to insulin glargine U100 (66% vs 65%, respectively).1 “We know that many people with type 2 diabetes prefer simplicity, meaning fewer injections and more convenience than what is currently provided with once- or twice-daily basal insulin treatment regimens,” said Dr Harpreet Bajaj, lead trial investigator and endocrinologist, LMC Diabetes & Endocrinology, Ontario, Canada. “This phase 2 trial demonstrates the potential benefit insulin icodec could offer to people with type 2 diabetes in need of insulin therapy, aiding easy transition onto a new treatment option without the daily burden and complexity that is associated with current therapies and potentially even experience more time in good glycaemic control with low risk of hypoglycaemia.” Key secondary endpoints included changes from baseline in HbA1c, which were not statistically significantly different for icodec with and without a loading dose compared to insulin glargine U100 (–0.77, –0.47 and –0.54 % points, respectively). Rates of clinically significant or severe hypoglycaemic episodes, also known as a hypo or low blood sugar, were similar between insulin icodec with a loading dose and insulin glargine U100 (observed rates of level 2 [
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