Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial.
Journal
The lancet. Diabetes & endocrinology
ISSN: 2213-8595
Titre abrégé: Lancet Diabetes Endocrinol
Pays: England
ID NLM: 101618821
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
10
12
2019
revised:
11
02
2020
accepted:
25
02
2020
pubmed:
26
4
2020
medline:
18
7
2020
entrez:
26
4
2020
Statut:
ppublish
Résumé
Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population. PIONEER 9 aimed to assess the dose-response of oral semaglutide and to compare the efficacy and safety of oral semaglutide with placebo and a subcutaneous GLP-1 receptor agonist in a Japanese population. PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan. Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out) were randomly assigned (1:1:1:1:1) to receive double-blind once-daily oral semaglutide (3 mg, 7 mg, or 14 mg) or placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg. The primary endpoint was change in HbA Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48). Changes in HbA This study showed that oral semaglutide provides significant reductions in HbA Novo Nordisk.
Sections du résumé
BACKGROUND
Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population. PIONEER 9 aimed to assess the dose-response of oral semaglutide and to compare the efficacy and safety of oral semaglutide with placebo and a subcutaneous GLP-1 receptor agonist in a Japanese population.
METHODS
PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan. Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out) were randomly assigned (1:1:1:1:1) to receive double-blind once-daily oral semaglutide (3 mg, 7 mg, or 14 mg) or placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg. The primary endpoint was change in HbA
FINDINGS
Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48). Changes in HbA
INTERPRETATION
This study showed that oral semaglutide provides significant reductions in HbA
FUNDING
Novo Nordisk.
Identifiants
pubmed: 32333875
pii: S2213-8587(20)30075-9
doi: 10.1016/S2213-8587(20)30075-9
pii:
doi:
Substances chimiques
Glucagon-Like Peptide-1 Receptor
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
hemoglobin A1c protein, human
0
semaglutide
53AXN4NNHX
Glucagon-Like Peptides
62340-29-8
Banques de données
ClinicalTrials.gov
['NCT03018028']
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
377-391Investigateurs
Y Fukushima
(Y)
Y Hamamoto
(Y)
A Hisatomi
(A)
Y Ide
(Y)
S Inoue
(S)
T Kawada
(T)
H Kim
(H)
A Kiyosue
(A)
K Matoba
(K)
O Matsuoka
(O)
H Nishimura
(H)
M Noguchi
(M)
T Osonoi
(T)
S Sawada
(S)
Y Shibasaki
(Y)
K Shin
(K)
Y Yamada
(Y)
Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.