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

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