Barcelona, Spain (ots/PRNewswire) - 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®
(empagliflozin 25 mg), Januvia® (sitagliptin 100 mg) or Victoza®
(liraglutide 1.8 mg). The results were presented today at the 55th
Annual Meeting of the European Association for the Study of Diabetes
(EASD). 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 (<=8.0%,
>8.0-<=9.0% and >9.0%). The proportion of people with type 2 diabetes
achieving an HbA1c target of <7% was greater with oral semaglutide 7
and 14 mg vs comparators in all trials and across all HbA1c baseline
"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
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 , Twitter , LinkedIn , YouTube .
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.
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