Novo Nordisk to present new data at the 80th Annual American Diabetes Association Scientific Sessions

Highlighted data to include 7 abstracts on Rybelsus® and 3 abstracts on investigational, once-weekly insulin icodec

PLAINSBORO, N.J., June 2, 2020 /PRNewswire/ -- Novo Nordisk announced that new data from 38 abstracts will be featured from the company's approved and investigational diabetes medicines at the upcoming 80th Annual Scientific Sessions of the American Diabetes Association (ADA). The meeting will be held virtually from June 12-16, 2020. The company is proud to continue its innovation in diabetes treatment with Rybelsus® (semaglutide) tablets 7 mg or 14 mg, as well as a phase 2 clinical trial of investigational, once-weekly insulin icodec.

Approved by the U.S. Food and Drug Administration in September 2019, Rybelsus® is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The following data on Rybelsus® will be presented during the meeting:

  • Glycemic and body weight responses to oral semaglutide in the PIONEER trial program (Poster 964-P)
  • Effect of oral semaglutide with or without background SGLT2i in patients with T2D: subgroup analysis of PIONEER 4 (Poster 927-P)
  • Efficacy and safety of oral semaglutide when added to basal, premix, or basal-bolus insulin (Poster 956-P)
  • Efficacy of oral semaglutide according to background medication: an exploratory subgroup analysis of the PIONEER trial program (Poster 957-P)
  • Efficacy of oral semaglutide according to race: an exploratory subgroup analysis of the PIONEER trial program (Poster 930-P)
  • Efficacy and safety of oral semaglutide by baseline age in the PIONEER clinical trial program (Poster 932-P)
  • Cost Effectiveness of Oral Semaglutide 14 mg vs Empagliflozin 25 mg in Canada (Poster 1193-P)

Results from a phase 2 clinical trial of investigational insulin icodec will be presented on June 14. Insulin icodec is an investigational, once-weekly basal insulin analogue. The following data will be presented during the meeting:

  • Once-weekly basal insulin icodec efficacy and safety vs once-daily insulin glargine U100 in insulin naïve patients with T2D (Oral 238-OR)
  • Molecular and biological properties of insulin icodec, an investigational insulin analog designed to have a long half-life suitable for once weekly dosing (Oral 236-OR)
  • Insulin icodec: an investigational insulin analog designed for once-weekly dosing in type 2 diabetes (Oral 237-OR)

In addition, the following data will also be presented at the meeting:

  • HbA1c levels and rates of hypoglycemia with insulin degludec U200 and insulin glargine U300 stratified by renal function subgroups: post hoc analysis from the CONCLUDE trial (Poster 1021-P)
  • Derived time-in-range and associated risk of MACE in T2D: data from the DEVOTE trial (Poster 21-LB)
  • Efficacy and safety of anti-interleukin (IL)-21 in combination with liraglutide in adults recently diagnosed with type 1 diabetes (Oral 278-OR)
  • GLP-1-experienced patients switching to once-weekly semaglutide in a real-world setting (EXPERT study) (Poster 954-P)
  • Optimal treatment intensification for glycemic control in patients with T2D on two oral agents: real world comparison of GLP-1, OADs and insulin (Poster 931-P)
  • Effect of late bolus injections on Time-in-Range studied by connected pens (Poster 975-P)

The above abstracts and presentations are a sampling of the data that will be presented or published by Novo Nordisk. This press release contains forward-looking statements about investigational products currently in development by Novo Nordisk. As is expected, there is significant risk with drug development and there is no guarantee that future studies will reflect similar results as presented at ADA. For further information about the Novo Nordisk drug pipeline, visit http://www.novonordisk.us.

About Rybelsus®
Rybelsus® (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone GLP-1. Rybelsus® is the first and only GLP-1 receptor agonist in a pill. It is administered once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg.

About insulin icodec 
Insulin icodec is an investigational, long-acting basal insulin analogue with a half-life of ~196 hours.1 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 volume of insulin required to be injected does not increase with once-weekly dosing, as insulin icodec is more concentrated than insulin glargine U100.

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.

References

  1. Hövelmann U, Brøndsted L, Kristensen NR, et al. Insulin Icodec: An Insulin Analog Suited For Once-weekly Dosing In Type 2 Diabetes. Presented at the 80th Scientific Sessions of the Virtual American Diabetes Association Annual Meeting. 2020.

Rybelsus® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2020 Novo Nordisk    All rights reserved.     US20RYB00386     June 2020

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SOURCE Novo Nordisk