PR84372

BAGSVAERD, Denmark, June 15, 2020/PRNewswire=KYODO JBN/--

This material is intended for global medical media only, excl US  

For journalistic assessment and preparation before publication.  

Today, 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.1

This 26-week, randomised, double-blind, double-dummy, treat-to-target phase 2

clinical trial involved 247 insulin-naive 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.1

"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.

For more news and media materials from Novo Nordisk at ADA 2020, visit:

www.epresspack.net/novonordiskADA2020/phase-2-once-weekly-insulin

About the phase 2 trial

This 26-week, randomised, 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-naive adults with type 2 diabetes

inadequately controlled with metformin ± a DPP-4i. The primary endpoint was

change in HbA1c from baseline to Week 26. Secondary endpoints included change

in fasting plasma glucose from baseline to Week 26 and hypoglycaemic 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 leading global healthcare company, founded in 1923 and

headquartered in Denmark. Our purpose is to drive change to defeat diabetes and

other serious chronic diseases such as obesity and rare blood and endocrine

disorders. We do so by pioneering scientific breakthroughs, expanding access to

our medicines and working to prevent and ultimately cure disease. Novo Nordisk

employs about 43,100 people in 80 countries and markets its products in around

170 countries. For more information, visit: https://www.novonordisk.com/,

Facebook, Twitter, LinkedIn, YouTube.

*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

Rosenstock J, Kjaersgaard MIS, Moller DV, et al. Once-Weekly Basal Insulin

Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine

U100 in Insulin Naive 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.

Hovelmann U, Brondsted 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.

Further information

Media:

Mette Kruse Danielsen

+45-4442-3883

mkd@novonordisk.com  

Investors:

Daniel Muusmann Bohsen

+45-3075-2175

dabo@novonordisk.com;

Valdemar Borum Svarrer

+45-3079-0301

jvls@novonordisk.com;

Ann Sondermolle Rendbaek  

+45-3075-2253

arnd@novonordisk.com;

Mark Joseph Root

+45-3079-4211

mjhr@novonordisk.com

Source: Novo Nordisk