NEW ORLEANS, March
23, 2019 /PRNewswire/ -- Oral semaglutide 7 mg and 14 mg
demonstrated superior A1C and body weight reductions compared to
Januvia® (sitagliptin 100 mg). Non-inferiority for oral
semaglutide 3 mg for A1C reduction 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) receptor
agonist 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,
TX. "The PIONEER 3 findings are encouraging, as oral
semaglutide demonstrated clinically significant improvement in A1C
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 endpoint of A1C 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 A1C 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 A1C 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<0.001).
When applying the secondary statistical approachb at
week 26, oral semaglutide 7 mg and 14 mg demonstrated statistically
significant reductions in A1C of 1.1% and 1.4%, respectively,
compared to a 0.8% reduction with sitagliptin (both p<0.001).
Reductions in A1C seen with oral semaglutide 3 mg were 0.5% and
compared to the reductions seen with sitagliptin, the difference is
statistically significant in favor of sitagliptin. Reductions in
body weight from baseline were statistically significant in favor
of all three oral semaglutide doses.
In a supportive secondary endpoint at 78 weeks, oral semaglutide
14 mg demonstrated statistically significant reductions in
A1C 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 or 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
program
PIONEER 3 was a 78-week, randomized, double-blind,
double-dummy, active-controlled, parallel-group, multicenter,
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 randomized 1,864
people in a 1:1:1:1 manner to receive either a dose of oral
semaglutide 3 mg, 7 mg or 14 mg or sitagliptin 100 mg once daily.
The primary endpoint was change in A1C, and the confirmatory
secondary endpoint was change in body weight, both from baseline to
week 26.
The PIONEER Phase 3a clinical development program for oral
semaglutide was a global development program that enrolled 9,543
people with type 2 diabetes across 10 clinical trials. The program
was completed in 2018.
About Novo Nordisk
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healthcare company that's been making innovative medicines to help
people with diabetes lead longer, healthier lives for 95 years.
This heritage has given us experience and capabilities that also
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a
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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.
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b
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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.
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Reference
1.
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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.
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reserved. US19OS00029
March 2019
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