Oral Semaglutide Demonstrated Significant Reduction in Blood Sugar vs Placebo in PIONEER 1 Trial

Orlando, Florida (ots/PRNewswire) -

Oral semaglutide, an investigational GLP-1 analogue taken as a
once-daily tablet, achieved significant reductions in blood sugar
versus placebo in adults with type 2 diabetes, according to findings
from the PIONEER 1 phase 3a trial. The trial evaluated the efficacy
and safety of 3, 7 and 14 mg oral semaglutide compared with placebo
as monotherapy over 26 weeks in adults with type 2 diabetes.1 The new
data will be presented tomorrow, 24 June, 2018 at the American
Diabetes Association's 78th Scientific Sessions (ADA) in Orlando, US.

Two distinct approaches to evaluating the effects of oral
semaglutide were applied in the PIONEER 1 trial; a primary approach
utilising an intention-to-treat principle required by recent
regulatory guidance, evaluating the treatment effect including the
effect of rescue medication and regardless of premature trial product
discontinuation; a secondary approach utilising an on-treatment
principle evaluated the treatment effect while on trial product and
without use of rescue medication.

Applying the intention-to-treat principle, the trial achieved its
primary objective by demonstrating that people treated with any of
the three doses of oral semaglutide achieved significant HbA1c
reductions compared to placebo (p<0.001 for all estimated treatment
differences in HbA1c for oral semaglutide vs placebo). Furthermore,
people treated with 14 mg oral semaglutide achieved significant
reductions (p<0.001) in weight vs placebo while weight reductions
with 7 mg and 3 mg doses did not reach statistical significance.1

"Despite advancements in the diabetes treatment landscape, many
people with type 2 diabetes still struggle to reach their HbA1c
target," said Vanita Aroda, MD, associate director, diabetes clinical
research, Brigham and Women's Hospital, Boston, MA, U.S. "Based on
the first results of PIONEER, I am optimistic about the potential of
having an oral GLP-1 receptor agonist that may help patients achieve
their HbA1c and blood sugar goals."

When applying the on-treatment principle, from a mean baseline
HbA1c of 8.0%, people treated with 3, 7 and 14 mg oral semaglutide
achieved HbA1c reductions of 0.8%, 1.3% and 1.5%, respectively,
compared to 0.1% with placebo.1 In addition, 59%, 72% and 80% of
people, respectively, treated with oral semaglutide achieved the ADA
treatment target of HbA1c below 7% compared to 34% treated with
placebo.1

Furthermore, when applying the on-treatment principle, people
treated with 3, 7 and 14 mg oral semaglutide experienced a weight
reduction of 1.7 kg, 2.5 kg and 4.1 kg, respectively, compared to 1.5
kg with placebo.1 Moreover, 21%, 29% and 44% of people treated with
oral semaglutide achieved a weight reduction of 5% or more compared
to 16% with placebo.1

The most common adverse events (>5%) were mild or moderate nausea,
which occurred in 5-16% of people treated with oral semaglutide and
diminished over time, compared with 6% in those treated with placebo.
Overall, adverse events were reported by 58%, 53% and 57% of people
treated with 3, 7 and 14 mg oral semaglutide, respectively, and in
56% of people treated with placebo. Treatment discontinuation due to
adverse events ranged from 2% to 7% for people treated with oral
semaglutide, compared to 2% for people treated with placebo.1

About oral semaglutide

Semaglutide is an analogue of human glucagon-like peptide-1
(GLP-1) that is provided in tablet formulation with an absorption
enhancer SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate).2
SNAC increases the bioavailability of semaglutide, facilitating
absorption of semaglutide from the stomach, thereby enabling oral
dosing.3 Oral semaglutide is in phase 3 development for blood sugar
control in adults with type 2 diabetes.

About PIONEER 1 and the PIONEER clinical trial programme

PIONEER 1 was a 26-week, randomised, double-blinded,
placebo-controlled, four-armed, parallel-group, multicentre,
multinational trial comparing the efficacy and safety of three dose
levels of once-daily oral semaglutide vs placebo in adults with type
2 diabetes treated with diet and exercise only. PIONEER 1 randomized
703 people in a randomised 1:1:1:1 manner to receive either a dose of
oral semaglutide (3, 7 or 14 mg) or placebo once daily. The primary
endpoint was change in HbA1c from baseline at week 26. The proportion
of patients achieving HbA1c of <7% and change in body weight were
secondary endpoints.

The PIONEER phase 3a clinical development programme for oral
semaglutide is a global development programme with enrolment of 8,845
adults with type 2 diabetes across 10 clinical trials, which are all
expected to complete in 2018.

About Novo Nordisk

Novo Nordisk is a global healthcare company with 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 42,700 people in 79 countries and markets its products
in more than 170 countries. For more information, visit
novonordisk.com (http://www.novonordisk.com), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk).

References

1. Aroda VR, Rosenstock J, Terauchi Y, et al. Effect And Safety
Of Oral Semaglutide Monotherapy In Type 2 Diabetes: PIONEER 1 Trial.
Abstract 2-LB. Presented at the 78th Scientific Sessions of the
American Diabetes Association, 22-26 June 2018, Orlando, Florida,
U.S. 2018.

2. Lau J, Bloch P, Schäffer L, et al. Discovery of the
Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
Journal of Medicinal Chemistry. 2015;58:7370-7380.

3. Davies M, Pieber T, Hartoft-Nielsen M L, et al. Effect of
Oral Semaglutide Compared with Placebo and Subcutaneous Semaglutide
on Glycaemic Control in Patients with Type 2 Diabetes. JAMA.
2017;318:1460-1470.

Further information

Media:

Katrine Sperling, +45-4442-6718, krsp@novonordisk.com

Åsa Josefsson, +45-3079-7708, aajf@novonordisk.com

Michael Bachner(US), +1-609-664-7308, mzyb@novonordisk.com

Investors:

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

Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com

Christina Kjær, +45-3079-3009, cnje@novonordisk.com

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