Oral semaglutide improves glycaemic control in people with type 2 diabetes across baseline blood sugar levels

PR80584

BARCELONA, Spain, Sept. 17, 2019, /PRNewswire=KYODO JBN/ --

Novo Nordisk today announced findings from an exploratory analysis of the

PIONEER trial programme, showing oral semaglutide (3, 7 and 14 mg) improved

glycaemic control in people with type 2 diabetes across baseline HbA1c levels.

Greater reductions in HbA1c were demonstrated with 7 mg and 14 mg oral

semaglutide vs all comparators including placebo, Jardiance(R) (empagliflozin 25

mg), Januvia(R) (sitagliptin 100 mg) or Victoza(R) (liraglutide 1.8 mg). The

results were presented today at the 55th Annual Meeting of the European

Association for the Study of Diabetes (EASD)[1]. Oral semaglutide is an

investigational once-daily glucagon-like peptide-1 (GLP-1) analogue in a pill.

In the analysis, data from 5,657 participants in PIONEER 1–5, 7 and 8 were

grouped by trial according to baseline HbA1c (less than or equal to 8.0%,

greater than 8.0 – less than or equal to 9.0% and greater than 9.0%). The

proportion of people with type 2 diabetes achieving an HbA1c target of less

than 7% was greater with oral semaglutide 7 and 14 mg vs comparators in all

trials and across all HbA1c baseline subgroups.

"People with type 2 diabetes have individual treatment goals related to

glycaemic control," said Dr Juris Meier, professor of medicine and head of the

division of diabetology and GI endocrinology at the St. Josef-Hospital of the

Ruhr-University of Bochum, Germany. "The findings from this analysis are

particularly meaningful as they show that oral semaglutide improves glycaemic

control in a wide spectrum of people with type 2 diabetes."

The safety profile of oral semaglutide across the PIONEER programme was

consistent with that of the GLP-1 receptor agonist class and similar to those

seen with subcutaneous semaglutide.

"This analysis reinforces the findings seen throughout the PIONEER trial

programme, demonstrating oral semaglutide's efficacy in HbA1c reductions

compared to commonly used type 2 diabetes treatments," said Mads Krogsgaard

Thomsen, executive vice president and chief science officer of Novo Nordisk.

"If approved, oral semaglutide will become the first and only oral GLP-1

receptor agonist with the potential to help people with uncontrolled type 2

diabetes better manage their condition."

About the exploratory analysis and the PIONEER clinical trial programme

The PIONEER 1-5, 7 and 8 trials, included in this analysis, investigated oral

semaglutide against diet and exercise (PIONEER 1), empagliflozin 25 mg (PIONEER

2), sitagliptin 100 mg (PIONEER 3 and 7), liraglutide 1.8 mg (PIONEER 4) and as

an add-on to insulin (PIONEER 8). PIONEER 5 evaluated oral semaglutide compared

to placebo in patients with moderate renal impairment.

The PIONEER phase 3a clinical development programme for oral semaglutide was a

global development programme that enrolled 9,543 people with type 2 diabetes

across 10 clinical trials.

Novo Nordisk is a global healthcare company with more than 95 years of

innovation and leadership in diabetes care. This heritage has given us

experience and capabilities that also enable us to help people defeat obesity,

haemophilia, growth disorders and other serious chronic diseases. Headquartered

in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries

and markets its products in more than 170 countries. For more information,

visit novonordisk.com, Facebook (https://www.facebook.com/novonordisk), Twitter

(https://twitter.com/novonordisk), LinkedIn

(https://www.linkedin.com/company/novo-nordisk),

YouTube(https://www.youtube.com/user/novonordisk/custom?app=desktop).

References

1. Meier JJ, Bauer R, Blicher TM, et al. Efficacy of oral semaglutide according

to baseline HbA1c: an exploratory subgroup analysis of the PIONEER trial

programme. 55th Annual Meeting of the European Association for the Study of

Diabetes. Barcelona, September 2019.

Further information:

Media:

Mette Kruse Danielsen: +45 3079 3883, mkd@novonordisk.com  

Ken Inchausti (US): +1 609 240 9429, kiau@novonordisk.com

Investors:

Peter Hugreffe Ankersen: +45 3075 9085, phak@novonordisk.com  

Valdemar Borum Svarrer: +45 3079 0301, jvls@novonordisk.com  

Ann Sondermolle Rendbæk: +45 3075 2253, arnd@novonordisk.com  

Kristoffer Due Berg (US): +1 609 235 2989, krdb@novonordisk.com  

Source: Novo Nordisk