Oral semaglutide 7 mg and 14 mg doses showed superior reductions in blood sugar and weight compared to sitagliptin at 26 weeks in data presented at ENDO

New Orleans (ots/PRNewswire) - Oral semaglutide 7 mg and 14 mg
demonstrated superior HbA1c and body weight reductions compared to
Januvia® (sitagliptin 100 mg). Non-inferiority for oral semaglutide 3
mg for HbA1c reductions at 26 weeks was not confirmed. Presented
today at the Endocrine Society Annual Meeting in New Orleans,
Louisiana, with simultaneous publication in the Journal of the
American Medical Association (JAMA)1, PIONEER 3 was a phase 3a trial
investigating the efficacy and long-term safety of oral semaglutide 3
mg, 7 mg and 14 mg compared with sitagliptin 100 mg in adults with
type 2 diabetes inadequately controlled with metformin, with or
without sulfonylurea, over 78 weeks. Oral semaglutide is an
investigational once-daily glucagon-like peptide-1 (GLP-1) analogue
in a pill.

"Many people living with type 2 diabetes do not meet their blood
glucose targets despite many available oral antidiabetic therapies,"
said Dr Dale Allison, PIONEER 3 investigator and director of medical
research at the Hillcrest Family Health Center, Waco, Texas. "The
PIONEER 3 findings are encouraging, as oral semaglutide demonstrated
a clinically significant improvement in HbA1c and this
investigational therapy has the potential to become the first oral
GLP-1 receptor agonist for those living with type 2 diabetes."

In PIONEER 3, the primary endpoints of HbA1c and confirmatory
secondary endpoint of change in body weight were assessed after 26
weeks of treatment. When applying the primary statistical approacha,
oral semaglutide 7 mg and 14 mg demonstrated superior HbA1c
reductions of 1.0% and 1.3% at 26 weeks, compared to a 0.8% reduction
with sitagliptin (both p<0.001). Oral semaglutide 3 mg demonstrated a
reduction in HbA1c of 0.6%; non-inferiority compared to sitagliptin
was not confirmed (p=0.09). Furthermore, at 26 weeks, oral
semaglutide 7 mg and 14 mg demonstrated superior body weight
reductions of 2.2 kg and 3.1 kg, both compared to a 0.6 kg reduction
for sitagliptin (p<0.01).

When applying the secondary statistical approachb at week 26, oral
semaglutide 7 mg and 14 mg demonstrated statistically significant
reductions in HbA1c of 1.1% and 1.4%, respectively, compared to a
0.8% reduction with sitagliptin (both p<0.001). Reductions in HbA1c
seen with oral semaglutide 3 mg were 0.5% and compared to the
reductions seen with sitagliptin, the difference is statistically
significant in favour of sitagliptin. Reductions in body weight from
baseline were statistically significant in favour of all three oral
semaglutide doses.

In a supportive secondary endpoint at week 78, oral semaglutide 14
mg demonstrated statistically significant reductions in HbA1c
compared to sitagliptin for both statistical approaches (1.1% vs
0.7%; p <0.001a; 1.1% vs 0.4%; p<0.001b). There was no statistically
significant difference with oral semaglutide 3 mg (both estimands) or
7 mg (TPol estimand) vs sitagliptin. Reductions in body weight from
baseline, which was dose dependent, were statistically significant
with oral semaglutide 3 mg, 7 mg and 14 mg at week 78 with reductions
of 1.8 kg, 2.7 kg and 3.2 kg, respectively, compared to a 1.0 kg
reduction with sitagliptin (all p<0.05a) and 1.9 kg, 2.7 kg and 3.5
kg, respectively, compared to a 1.1 kg reduction with sitagliptin
(all p<0.05b).

In this 78-week trial, the most common adverse event for oral
semaglutide was nausea, which was dose dependent, affecting 7.3% to
15.1%. The nausea rate for sitagliptin was 6.9%. People taking oral
semaglutide 3 mg, 7 mg and 14 mg reported serious adverse events at a
rate of 13.7%, 10.1% and 9.5%, respectively, compared to a rate of
12.4% of those taking sitagliptin. The proportion of people who
discontinued treatment due to adverse events was 5.6%, 5.8% and 11.6%
for people treated with oral semaglutide 3 mg, 7 mg and 14 mg,
respectively, compared to 5.2% with sitagliptin.

About PIONEER 3 and the PIONEER clinical trial programme

PIONEER 3 was a 78-week, randomised, double-blind, double-dummy,
active-controlled, parallel-group, multicentre, multinational trial
with four arms comparing the efficacy and safety of oral semaglutide
3 mg, 7 mg and 14 mg with sitagliptin 100 mg in people with type 2
diabetes inadequately controlled with metformin, with or without
sulfonylurea. PIONEER 3 randomised 1,864 people in a 1:1:1:1 manner
to receive either a dose of oral semaglutide 3 mg, 7 mg and 14 mg or
sitagliptin 100 mg once daily. The primary endpoint was change in
HbA1c, and the confirmatory secondary endpoint was change in body
weight, both from baseline to week 26.

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. The programme
was completed in 2018.

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 43,200 people in 80 countries and markets its
products in more than 170 countries. For more information, visit
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(http://www.youtube.com/novonordisk).

a In PIONEER 3, two distinct statistical approaches were used to
evaluate the effects of oral semaglutide. The primary statistical
approach is known as the treatment policy (TPol) estimand and it was
used to assess the effects of oral semaglutide regardless of
discontinuation of trial product and/or use of rescue medication.

b The secondary statistical approach is known as the trial product
estimand and it was used to assess the effect of oral semaglutide,
assuming all patients remained on trial product and did not use
rescue medication.

Further information

Media:
Mette Kruse Danielsen +45 4442 3883 mkd@novonordisk.com
Michael Bachner (US) +1 609 664 7308 mzyb@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com
Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com
Kristoffer Due Berg (US) +1 609 235 2989 krdb@novonordisk.com

References

1. Rosenstock J, et al. Effect of Additional Oral Semaglutide vs
Sitagliptin on Glycated Hemoglobin in Adults with Type 2 Diabetes
Uncontrolled with Metformin alone or with Sulfonylurea: the PIONEER 3
Randomized Clinical Trial. JAMA. 2019;321(15):1-15.
doi:10.1001/jama.2019.2942.

ots Originaltext: Novo Nordisk A/S
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