Investigational, once-weekly insulin icodec showed comparable efficacy and safety to once-daily insulin glargine U100 in phase 2 trial

PLAINSBORO, N.J., June 14, 2020 /PRNewswire/ -- Today, Novo Nordisk announced results from a phase 2 clinical trial of investigational insulin icodec, a once-weekly basal insulin analog. 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. Results were presented during the 80^th Scientific Sessions of the American Diabetes Association.¹

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.

About the phase 2 trial
This 26-week, randomized, double-blind, double-dummy, treat-to-target phase 2 clinical trial of once-weekly insulin icodec compared with once-daily insulin glargine U100* involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin ± a DPP-4i. The primary endpoint was change in A1C from baseline to Week 26. Secondary endpoints included change in fasting plasma glucose from baseline to Week 26 and hypoglycemic episodes. This phase 2 trial was conducted in the US, Canada, Czech Republic, Greece, Poland, Slovakia and Slovenia.

About insulin icodec
Insulin icodec is an investigational, long-acting basal insulin analogue with a half-life of 196 hours.² Once injected, insulin icodec binds strongly but reversibly to albumin. This results in a continuous, slow and steady reduction of blood sugar over the week. The injection volume of once-weekly insulin icodec is equivalent to daily insulin glargine U100 due to the concentrated formulation.

About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

*NCT03751657: A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

References

1. Rosenstock J, Kjærsgaard MIS, Møller DV, et al. Once-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine U100 in Insulin Naïve Patients with T2D Inadequately Controlled on OADs. Abstract 238-OR. Presented at the 80th Scientific Sessions of the Virtual American Diabetes Association Annual Meeting, Insulin Therapies, 18:15 CDT on 14 June 2020.
2. Hövelmann U, Brøndsted L, Kristensen NR. et al. Insulin Icodec: An Insulin Analog Suited for Once-Weekly Dosing in Type 2 Diabetes. Abstract 237-OR. Presented at the 80th Scientific Sessions of the American Diabetes Association, Insulin Therapies, 18:00 CDT on 14 June 2020.

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