PMID- 31692244
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 22
IP  - 3
DP  - 2020 Mar
TI  - Efficacy and safety of empagliflozin as add-on to insulin in Japanese patients 
      with type 2 diabetes: A randomized, double-blind, placebo-controlled trial.
PG  - 417-426
LID - 10.1111/dom.13909 [doi]
AB  - AIM: To assess the efficacy and safety of empagliflozin as add-on to insulin in 
      Japanese patients with type 2 diabetes (T2D). MATERIALS AND METHODS: This 
      multicentre, double-blind, parallel-group study randomized Japanese patients with 
      T2D insufficiently controlled with insulin (1:1:1) to empagliflozin 10 mg (n=89), 
      empagliflozin 25 mg (n=90) or placebo (n=90) for 52 weeks. The primary endpoint 
      was change from baseline in glycated haemoglobin (HbA1c) at 16 weeks. RESULTS: At 
      16 weeks, empagliflozin 10 mg and 25 mg significantly decreased HbA1c: adjusted 
      mean difference -0.92% (95% confidence interval [CI] -1.11, -0.73) and -1.00% 
      (95% CI -1.18, -0.82; both P<0.0001) compared with placebo. This difference was 
      maintained up to 52 weeks: adjusted mean difference at 52 weeks -0.90% (95% CI 
      -1.09, -0.70) and -0.96% (95% CI -1.15, -0.77; both P<0.0001). At 52 weeks, 
      significant improvements in fasting plasma glucose (adjusted mean difference 
      -27.62 mg/dL [95% CI -36.15, -19.08] and -31.99 mg/dL [95% CI -40.35, -23.62]) 
      and in body weight (-1.78 kg [95% CI -2.46, -1.10] and -1.92 kg [95% CI -2.58, 
      -1.25]) were also seen with empagliflozin 10 mg and 25 mg compared with placebo 
      (all P<0.0001). At 52 weeks, the frequency of adverse events (AEs) and serious 
      AEs was similar in the three treatment groups; confirmed hypoglycaemia was 
      reported slightly more in participants in the empagliflozin 10 mg and 25 mg 
      groups (23.3% and 22.2% vs 14.4%). All hypoglycaemic events were mild in 
      severity; no episodes required assistance. CONCLUSIONS: In Japanese patients with 
      insufficiently controlled T2D, adding empagliflozin 10 mg or 25 mg to insulin 
      treatment was associated with clinically meaningful reductions in HbA1c at 
      16 weeks and was generally well tolerated.
CI  - (c) 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Sone, Hirohito
AU  - Sone H
AUID- ORCID: 0000-0003-1263-2817
AD  - Department of Hematology, Endocrinology and Metabolism, Niigata University 
      Graduate School of Medical and Dental Sciences, Niigata, Japan.
FAU - Kaneko, Tatsuroh
AU  - Kaneko T
AD  - Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
FAU - Shiki, Kosuke
AU  - Shiki K
AUID- ORCID: 0000-0002-0928-050X
AD  - Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
FAU - Tachibana, Yoshifumi
AU  - Tachibana Y
AD  - Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
FAU - Pfarr, Egon
AU  - Pfarr E
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Lee, Jisoo
AU  - Lee J
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Tajima, Naoko
AU  - Tajima N
AD  - Jikei University School of Medicine, Tokyo, Japan.
LA  - eng
GR  - Nippon Boehringer Ingelheim Co. Ltd./International
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191220
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Benzhydryl Compounds/adverse effects
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Glucosides
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Insulin/therapeutic use
MH  - Japan/epidemiology
MH  - Treatment Outcome
PMC - PMC7065067
OTO - NOTNLM
OT  - Japanese
OT  - empagliflozin
OT  - insulin
OT  - sodium-glucose co-transporter-2 inhibitor
OT  - type 2 diabetes
COIS- H.S. has received consulting fees and/or speakers' bureau fees from Nippon 
      Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd. and MSD K.K. and has 
      received research support from Takeda Pharmaceutical Co., Ltd., Ono 
      Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Taisho Pharma Co., Ltd. 
      and Novartis Pharma K.K. N.T. has received speakers' bureau fees from Nippon 
      Boehringer Ingelheim Co., Ltd. and Takeda Pharmaceutical Co., Ltd. T.K., K.S. and 
      Y.T. are employees of Nippon Boehringer Ingelheim Co., Ltd. E.P. and J.L. are 
      employees of Boehringer Ingelheim Pharma GmbH & Co. KG.
EDAT- 2019/11/07 06:00
MHDA- 2021/06/25 06:00
PMCR- 2020/03/11
CRDT- 2019/11/07 06:00
PHST- 2019/05/30 00:00 [received]
PHST- 2019/10/25 00:00 [revised]
PHST- 2019/10/31 00:00 [accepted]
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2019/11/07 06:00 [entrez]
PHST- 2020/03/11 00:00 [pmc-release]
AID - DOM13909 [pii]
AID - 10.1111/dom.13909 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2020 Mar;22(3):417-426. doi: 10.1111/dom.13909. Epub 2019 
      Dec 20.