Views: 0 Author: Site Editor Publish Time: 2020-09-22 Origin: Novo Nordisk A/S, GlobeNewswire
BAGSVÆRD, Denmark, Sept. 22, 2020 /PRNewswire/ -- 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).
"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 [<3 mmol/L] and 3 [severe] hypoglycaemia were 0.78 and 0.79 events per patient year of exposure for insulin icodec and insulin glargine U100, respectively), and numerically lower for insulin icodec without a loading dose (0.15 events per patient year of exposure). No new safety issues were identified in relation to once-weekly insulin icodec and no severe episodes occurred in this trial.
Data comparing the effect of different titration algorithms of insulin icodec with insulin glargine U100 to better understand the optimal titration for a once-weekly basal insulin in people with type 2 diabetes who were inadequately controlled with oral antidiabetics were also presented at the meeting. In this 16-week trial, all three once-weekly titration algorithms for insulin icodec investigated were shown to be well-tolerated and efficacious, and demonstrated an improved or similar 'time in range' versus once-daily insulin glargine U100, depending on the titration algorithm applied.
Results from the 26-week phase 2 clinical trial in insulin-naïve adults with type 2 diabetes where insulin icodec demonstrated comparable blood sugar lowering and a similar safety profile to once-daily insulin glargine U100 were also presented at the EASD Annual Meeting and simultaneously published in the New England Journal of Medicine.5,6 The data were previously presented at the 80th Scientific Sessions of the American Diabetes Association in June 2020.
"As a leader in diabetes innovation, Novo Nordisk understands that there is a need to continue to offer innovative treatment options to support people living with diabetes and improve outcomes," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "We are excited by the phase 2 data that have been presented at EASD 2020 and ADA 2020 for insulin icodec, which demonstrated its efficacy and tolerability, and has the potential to offer a simplified treatment option for people with type 2 diabetes initiating insulin treatment, as well as the option for those to switch."
The phase 2 trials will inform the trial designs for the phase 3 clinical development programme for once-weekly insulin icodec, which Novo Nordisk will initiate later in 2020.