Oral semaglutide showed superior reductions in blood sugar vs Jardiance® and non-inferior blood sugar reductions vs Victoza® in adults with type 2 diabetes at 26 weeks

Abstracts 54-OR and 55-OR

Secondary data at 52 weeks demonstrated statistically significant
blood sugar reductions and statistically significant reduction of
body weight vs both Jardiance® and Victoza®

San Francisco (ots/PRNewswire) - Findings presented today from two
phase 3a clinical trials evaluated oral semaglutide 14 mg vs
Jardiance® (empagliflozin 25 mg) in PIONEER 2 and oral semaglutide 14
mg versus Victoza® (liraglutide 1.8 mg) in PIONEER 4 over 52 weeks in
adults with type 2 diabetes. Data from both trials were presented at
the American Diabetes Association (ADA) 79th Scientific Sessions.
Oral semaglutide is an investigational once-daily glucagon-like
peptide-1 (GLP-1) analogue in a pill.

In PIONEER 2, oral semaglutide 14 mg demonstrated a superior HbA1c
reduction of 1.3% compared to a 0.9% reduction with empagliflozin 25
mg for the primary endpoint at 26 weeks (p<0.0001) and a
statistically significant reduction in HbA1c for the secondary
endpoint at 52 weeks. Furthermore, for the secondary endpoint, the
reduction in body weight with oral semaglutide was similar to
empagliflozin with no statistical differences at both 26 and 52 weeks
(3.8 kg for oral semaglutide at both 26 and 52 weeks, 3.7 kg and 3.6
kg for empagliflozin, respectively).

In PIONEER 4, for the primary endpoint at 26 weeks, oral
semaglutide 14 mg demonstrated a non-inferior reduction in HbA1c vs
Victoza® (1.2% vs 1.1%, respectively) and a superior reduction vs
placebo (1.2% vs 0.2%, respectively) in adults with type 2 diabetes
inadequately controlled on metformin, with or without a
sodium-glucose co-transporter-2 (SGLT-2) inhibitor. For the secondary
endpoint at 52 weeks, oral semaglutide demonstrated statistically
significant reductions in HbA1c vs both Victoza® (1.2% vs 0.9%,
respectively) and placebo (1.2% vs 0.2%, respectively). For the
secondary endpoint of change in body weight, oral semaglutide
demonstrated superior reductions compared to both Victoza® and
placebo at 26 weeks (4.4 kg for oral semaglutide, 3.1 kg for Victoza®
and 0.5 kg for placebo) and statistically significant reductions
compared to both at 52 weeks (4.3 kg for oral semaglutide, 3.0 kg for
Victoza® and 1.0 kg for placebo).

In PIONEER 2, the most common adverse event for oral semaglutide
was nausea, which diminished over time, affecting 20% of people
treated with oral semaglutide. The nausea rate for empagliflozin was
2%. The proportion of people who discontinued treatment due to
adverse events was 11% for those treated with oral semaglutide
compared to 4% for those treated with empagliflozin.

In PIONEER 4, the most common adverse event for oral semaglutide
was nausea, which diminished over time, affecting 20% of people
treated with oral semaglutide. For people treated with Victoza® and
placebo, 18% and 4%, respectively, experienced nausea. The proportion
of people who discontinued treatment due to adverse events was 11%
for those treated with oral semaglutide compared to 9% with Victoza®
and 4% with placebo.

These results are based on the primary statistical approach known
as the treatment policy (TPol) estimand, which was used to assess the
effects of oral semaglutide regardless of discontinuation of trial
product and/or use of rescue medication.

"Despite their proven safety and efficacy, GLP-1 receptor agonists
are underutilised in clinical care" said Ildiko Lingvay, PIONEER 2
and 4 investigator and professor at the Departments of Internal
Medicine and Clinical Sciences, University of Texas Southwestern
Medical Center, Dallas, Texas. "As a treating physician, I'm
encouraged by these findings and the potential of investigational
oral semaglutide to be the first oral GLP-1 receptor agonist
available as a new treatment option for people living with type 2
diabetes."

The following results from PIONEER 2 and 4 were also presented
today at the ADA and are based on the secondary statistical approach.
The secondary statistical approach is known as the trial product
estimand and is used to assess the effect of oral semaglutide,
assuming all patients remained on trial product and did not use
rescue medication:

PIONEER 2:

- Oral semaglutide demonstrated statistically significant reductions
in HbA1c vs empagliflozin at 26 weeks (1.4% vs 0.9%, respectively)
and at 52 weeks (1.3% vs 0.8%, respectively).
- Oral semaglutide demonstrated a body weight reduction of 4.2 kg vs
3.8 kg with empagliflozin at 26 weeks and a statistically
significant reduction of 4.7 kg vs 3.8 kg at 52 weeks.

PIONEER 4:

- Oral semaglutide demonstrated statistically significant reductions
in HbA1c vs Victoza® and vs placebo at both 26 and 52 weeks (1.3%
for oral semaglutide, 1.1% for Victoza® and 0.1% for placebo at 26
weeks; 1.2% for oral semaglutide, 0.9% for Victoza® and a 0.2%
increase for placebo at 52 weeks).
- Oral semaglutide demonstrated statistically significant reductions
in body weight vs Victoza® and vs placebo at both 26 and 52 weeks
(4.7 kg for oral semaglutide, 3.2 kg for Victoza® and 0.7 kg for
placebo at 26 weeks; 5.0 kg for oral semaglutide, 3.1 kg for
Victoza® and 1.2 kg for placebo at 52 weeks).

About PIONEER 2, PIONEER 4 and the PIONEER clinical trial
programme

PIONEER 2 was a 52-week, randomised, open-label,
active-controlled, parallel-group, multicentre, multinational trial
with two arms comparing the efficacy and safety of oral semaglutide
14 mg with empagliflozin 25 mg in people with type 2 diabetes,
inadequately controlled on metformin. 822 people were enrolled in
PIONEER 2 and randomised 1:1 to receive either oral semaglutide or
empagliflozin once daily. The primary endpoint was change in HbA1c
from baseline to week 26 and the confirmatory secondary endpoint was
change in body weight from baseline to week 26. Additional key
secondary endpoints included change in HbA1c and body weight from
baseline to week 52.

PIONEER 4 was a 52-week, randomised, double-blinded, double-dummy,
active- and placebo-controlled, parallel-group, multicentre,
multinational trial with three arms comparing the efficacy and safety
of oral semaglutide 14 mg compared to Victoza® (1.8 mg liraglutide)
or placebo in people with type 2 diabetes, inadequately controlled on
metformin with or without an SGLT-2 inhibitor. PIONEER 4 randomised
711 people in a 2:2:1 manner to receive either oral semaglutide,
Victoza® or placebo once-daily. The primary endpoint was change from
baseline to week 26 in HbA1c. Key secondary endpoints included change
in HbA1c and body weight from baseline to week 52.

The PIONEER phase 3a clinical development programme for oral
semaglutide is 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 43,200 people in 80 countries and markets its
products in more than 170 countries. For more information, visit
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References

1. Montanya E, Rosenstock J, Canani LH, et al. Oral semaglutide vs
empagliflozin added-on to metformin monotherapy in uncontrolled
type 2 diabetes: PIONEER 2. Abstract number 54-OR, American
Diabetes Association 79th Scientific Session, San Francisco, US;
7-11 June 2019
2. Pratley RE, Amod A, Hoff ST, et al. Oral Semaglutide vs
Liraglutide and Placebo in T2D: PIONEER 4. Abstract number 55-OR,
American Diabetes Association 79th Scientific Session, San
Francisco, US; 7-11 June 2019

Further information

Media:
Katrine Sperling +45 4442 6718 krsp@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

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