Novel insulin found as effective as insulin glargine in phase 2 trial

PLAINSBORO - Researchers have announced results from a phase 2 clinical trial of investigational insulin icodec, a once-weekly basal insulin analog which were presented during the 80th Scientific Sessions of the American Diabetes Association.

In the trial, adults with type 2 diabetes randomized to once-weekly insulin icodec achieved similar blood sugar control and a similar safety profile compared to adults with type 2 diabetes randomized to once-daily insulin glargine U100.

This 26-week, randomized, 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 (A1C) was similar in participants receiving once-weekly insulin icodec compared to once-daily insulin glargine U100 (-1.33 vs -1.15 percentage 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."

Hypoglycemia, 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] hypoglycemia 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.1

"Novo Nordisk continues to be a leader in insulin innovation, advancing research for nearly 100 years in order to help improve the lives of those living with diabetes," said Todd Hobbs, vice president and chief medical officer for Novo Nordisk in the US. "Data from our phase 2 trial of investigational, once-weekly icodec showed that in terms of efficacy and safety, icodec was comparable to insulin glargine U100 and could provide those living with type 2 diabetes a new option allowing for a reduction in the amount of basal insulin injections from seven to once per week."

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