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Novo Nordisk announces Phase 2 results

Novo Nordisk CMC Development

Novo Nordisk announced results from a phase 2 clinical trial of investigational insulin icodec, a once-weekly basal insulin analogue.

In the trial, adults with type 2 diabetes randomised to once-weekly insulin icodec achieved similar blood sugar control and a similar safety profile compared with adults with type 2 diabetes randomised to once-daily insulin glargine U100. Results were presented during the 80th Scientific Sessions of the American Diabetes Association.

Reduce the number of basal insulin injections

This 26-week, randomised, double-blind, double-dummy, treat-to-target phase 2 clinical trial involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin with or without a DPP-4i. The primary endpoint showed that the change from baseline to week 26 in blood sugar control (HbA1c) was similar in participants receiving once-weekly insulin icodec compared to once-daily insulin glargine U100 (-1.33% vs -1.15% points, respectively, p=0.08).1 Secondary endpoints included change in fasting plasma glucose (FPG) from baseline to week 26, which was similar for insulin icodec and insulin glargine U100 (-58mg/dL and -54mg/dL respectively), and the change from baseline to week 26 of the mean of the nine-point self-monitoring of blood glucose (SMBG) profile, which was greater for icodec (-7.9 mg/dL; p= 0.01).1

“Many people with type 2 diabetes are reluctant to start on insulin therapy due to the need for daily injections,” said Dr Julio Rosenstock, lead trial investigator and clinical professor of medicine, University of Texas Southwestern Medical Center, US. “I’m truly excited about the potential of such innovative treatments which could reduce the number of basal insulin injections for my patients with diabetes.”

Phase 3 later in 2020

Hypoglycaemia, also known as a hypo or low blood sugar, was similar for both treatment groups (observed rates of level 2 [<54 mg/dL] and 3 [severe] hypoglycaemia were 52.5 and 45.6 events per 100 patient years of exposure for insulin icodec and insulin glargine U100 respectively). No new safety issues were identified in relation to once-weekly insulin icodec in this trial. The proportion of patients that had an adverse event was similar between the insulin icodec and glargine U100 arms.

“Novo Nordisk has been at the forefront of insulin innovation for almost 100 years, and we continuously conduct disruptive research that can lead to fundamentally more convenient and improved treatments with the potential to change the lives of people with diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “This phase 2 trial showed that once-weekly insulin icodec was comparable to insulin glargine U100 in terms of efficacy and safety, it could provide people with type 2 diabetes with a new option that, among other things, would reduce the number of basal insulin injections to one a week.”

Novo Nordisk expects to initiate the phase 3 clinical development programme for once-weekly insulin icodec later in 2020.

Image caption: Novo Nordisk CMC Development, Mikkel Stavnsbjerg and Phaedria Marie St Hilaire: Novo Nordisk