ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Oral semaglutide,
an investigational GLP-1 receptor agonist 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,
June 24, 2018 at the American
Diabetes Association's 78th Scientific Sessions (ADA) in
Orlando, Fla.
Two distinct approaches to evaluating the effects of oral
semaglutide were applied in the PIONEER 1 trial; a primary approach
utilizing an intention-to-treat principle required by recent
regulatory guidance, evaluating the treatment effect including the
effect of any rescue medication and regardless of premature trial
product discontinuation; a secondary approach utilizing 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 A1C
reductions compared to placebo (p<0.001 for all estimated
treatment differences [ETD] in A1C 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 A1C
target," said Vanita Aroda,
associate director, diabetes clinical research, 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 A1C and
blood sugar goals."
When applying the on-treatment principle, from a mean baseline
A1C of 8.0%, people treated with 3, 7 and 14 mg oral semaglutide
achieved A1C reductions of 0.8%, 1.3% and 1.5%, respectively,
compared to 0.1% with placebo (p<0.001 vs placebo for ETD of
oral semaglutide vs placebo).1 In addition, 59%, 72% and
80% of people respectively treated with oral semaglutide achieved
the ADA treatment target of A1C below 7%, compared to 34% treated
with placebo (p<0.001 for odds for achieving the
target).1
Furthermore, when applying the on-treatment principle, people
treated with 3, 7 and 14 mg oral semaglutide experienced a weight
loss of 1.7 kg (3.7 lb), 2.5 kg (5.5 lb) and 4.1 kg (9.0 lb),
respectively, compared to 1.5 kg (3.3 lb) with placebo (p<0.001
for ETD of oral semaglutide 14 mg vs placebo, p<0.05 for oral
semaglutide 7 mg vs placebo, oral semaglutide 3 mg vs placebo was
not statistically significant).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
Oral 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 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 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 A1C from baseline at week
26. The proportion of patients achieving A1C 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 enrollment 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, a
global healthcare company, has been committed to discovering and
developing innovative medicines to help people living with diabetes
lead longer, healthier lives for 95 years. This heritage has given
us experience and capabilities that also enable us to help people
defeat other serious diseases including obesity, hemophilia and
growth disorders. We remain steadfast in our conviction that the
formula for success is to stay focused, think long term and do
business in a financially, socially and environmentally responsible
way. With U.S. headquarters in New
Jersey and production and research facilities in four
states, Novo Nordisk employs nearly 6,000 people throughout the
country. For more information, visit novonordisk.us,
Facebook and Twitter.
_______________________
References
1.
|
Aroda VR, Rosenstock
J, Terauchi Y, et al. Phase 3 Clinical Study Investigating
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
|
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US18OZM00238
June 2018
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