ORLANDO, Florida, June 23, 2018 /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, Facebook,
Twitter, LinkedIn,
YouTube.
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