PMID- 29862617
OWN - NLM
STAT- MEDLINE
DCOM- 20190128
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 10
DP  - 2018 Oct
TI  - Efficacy and safety of trelagliptin in combination with insulin therapy in 
      Japanese patients with type 2 diabetes: Results from a randomized, Phase IV 
      study.
PG  - 2490-2493
LID - 10.1111/dom.13397 [doi]
AB  - We aimed to explore the efficacy and safety of once-weekly trelagliptin 100 mg as 
      an add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus 
      with inadequate glycaemic control. Patients with haemoglobin A1c (HbA1c) 7.5% to 
      10.0% who were receiving 8 to 40 units of insulin per day were randomized to 
      receive, with insulin, trelagliptin 100 mg (A/A, n = 116) or placebo (P/A, n = 
      124) for a 12-week double-blind (DB) phase, after which all received trelagliptin 
      for a 40-week open-label phase. Primary endpoints were HbA1c change from baseline 
      to the end of the DB phase and adverse events (AEs). HbA1c significantly 
      decreased in the A/A group vs the P/A group at the end of the DB phase (least 
      square mean difference, -0.63% [95% CI, -0.83 to -0.44]: P < .0001). The 
      frequency of treatment-emergent AEs during the DB phase was 44.0% in the A/A 
      group and 47.6% in the P/A group. No patient experienced severe hypoglycaemia 
      during trelagliptin treatment. Once-weekly trelagliptin 100 mg therapy with 
      insulin demonstrated a significant reduction in HbA1c. Long-term treatment was 
      well-tolerated, with no clinically significant hypoglycaemia, suggesting that 
      trelagliptin with insulin is a meaningful treatment option in this patient 
      population.
CI  - (c) 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Kaku, Kohei
AU  - Kaku K
AUID- ORCID: 0000-0003-1574-0565
AD  - Department of Medicine, Kawasaki Medical School, Okayama, Japan.
FAU - Kuroda, Shingo
AU  - Kuroda S
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan.
FAU - Ishida, Kazuyuki
AU  - Ishida K
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan.
FAU - Umeda, Yuusuke
AU  - Umeda Y
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan.
LA  - eng
GR  - Takeda Pharmaceutical Company Limited/International
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180702
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin)
RN  - 56HH86ZVCT (Uracil)
RN  - Q836OWG55H (trelagliptin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People
MH  - Blood Glucose/drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/drug effects/metabolism
MH  - Humans
MH  - Insulin/*administration & dosage/adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Uracil/administration & dosage/adverse effects/*analogs & derivatives
PMC - PMC6175153
OTO - NOTNLM
OT  - anti-diabetic drug
OT  - clinical trial
OT  - insulin therapy
OT  - phase IV study
OT  - randomized trial
OT  - type 2 diabetes
COIS- K. K. has received research funding, consultancy fees or lecture fees from 
      Astellas Pharma, AstraZeneca, Novo Nordisk Pharma, Eli Lilly, Sanwakagaku 
      Kenkyusho, Takeda Pharmaceutical, Taisho Pharmaceutical, MSD, Daiichi-Sankyo, 
      Mitsubishi Tanabe Pharma, Boehringer-Ingelheim, and Ono Pharmaceutical; he has no 
      other relevant affiliations or financial involvement with any organization or 
      entity with a financial interest in or financial conflict with the subject matter 
      or materials discussed in the manuscript apart from those disclosed. S. K., K. I. 
      and Y. U. are employees of Takeda Pharmaceutical Company Limited.
EDAT- 2018/06/05 06:00
MHDA- 2019/01/29 06:00
PMCR- 2018/10/08
CRDT- 2018/06/05 06:00
PHST- 2018/01/30 00:00 [received]
PHST- 2018/05/16 00:00 [revised]
PHST- 2018/05/26 00:00 [accepted]
PHST- 2018/06/05 06:00 [pubmed]
PHST- 2019/01/29 06:00 [medline]
PHST- 2018/06/05 06:00 [entrez]
PHST- 2018/10/08 00:00 [pmc-release]
AID - DOM13397 [pii]
AID - 10.1111/dom.13397 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Oct;20(10):2490-2493. doi: 10.1111/dom.13397. Epub 2018 
      Jul 2.