PMID- 24708292
OWN - NLM
STAT- MEDLINE
DCOM- 20150608
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 30
IP  - 7
DP  - 2014 Jul
TI  - Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with 
      type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 
      study.
PG  - 1245-55
LID - 10.1185/03007995.2014.912983 [doi]
AB  - OBJECTIVE: Luseogliflozin--a novel, orally bioavailable, 1-thio-D-glucitol 
      derivative and a selective sodium glucose cotransporter 2 inhibitor--has shown 
      efficacy and tolerability in previous phase 2 studies. This phase 3, randomized, 
      double-blind, placebo-controlled, comparative study aimed to confirm the 
      superiority of 24 week luseogliflozin 2.5 mg monotherapy over placebo in reducing 
      hemoglobin A1c (HbA1c) levels in Japanese patients with type 2 diabetes mellitus 
      (T2DM). METHODS: Patients with HbA1c levels of 6.9%-10.5% were randomized to 
      receive luseogliflozin 2.5 mg or placebo once daily for 24 weeks (n = 79 in each 
      group). The primary endpoint was change from baseline in HbA1c at end of 
      treatment. Secondary endpoints included change from baseline in fasting plasma 
      glucose (FPG) and postprandial plasma glucose (PPG) following a meal tolerance 
      test, body weight, and abdominal circumference. Safety assessments included 
      adverse events (AEs), clinical laboratory tests, and vital signs. RESULTS: At the 
      end of treatment, HbA1c was significantly decreased from baseline in the 
      luseogliflozin 2.5 mg group (-0.63%) versus the placebo group (0.13%), with a 
      between-group difference of -0.75% (p < 0.001). Additionally, significant 
      reductions in FPG, PPG, body weight, and abdominal circumference were noted with 
      luseogliflozin compared with placebo (all p < 0.05). Luseogliflozin was well 
      tolerated; there was no significant difference between groups in the incidence of 
      AEs (luseogliflozin, 59.5%; placebo, 57.0%). No AEs led to study drug 
      discontinuation. Most AEs were mild in severity, with no severe AE reported. 
      Limitations of this study include its short study duration and small sample size. 
      CONCLUSION: Luseogliflozin monotherapy for 24 weeks was superior to placebo in 
      reducing HbA1c levels. It also reduced FPG, PPG, body weight, and abdominal 
      circumference and was well tolerated in Japanese patients with T2DM. CLINICAL 
      TRIAL REGISTRATION: JapicCTI-111661.
FAU - Seino, Yutaka
AU  - Seino Y
AD  - Kansai Electric Power Hospital , Osaka , Japan.
FAU - Sasaki, Takashi
AU  - Sasaki T
FAU - Fukatsu, Atsushi
AU  - Fukatsu A
FAU - Ubukata, Michito
AU  - Ubukata M
FAU - Sakai, Soichi
AU  - Sakai S
FAU - Samukawa, Yoshishige
AU  - Samukawa Y
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140429
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 506T60A25R (Sorbitol)
RN  - C596HWF74Z 
      (1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Asian People
MH  - Biomarkers/blood
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/ethnology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Sorbitol/*analogs & derivatives/therapeutic use
MH  - Treatment Outcome
MH  - Weight Loss
OTO - NOTNLM
OT  - Japanese
OT  - Luseogliflozin
OT  - Monotherapy
OT  - Phase 3 clinical study
OT  - Placebo-controlled
OT  - Sodium glucose cotransporter 2 inhibitor
OT  - Type 2 diabetes mellitus
EDAT- 2014/04/09 06:00
MHDA- 2015/06/09 06:00
CRDT- 2014/04/09 06:00
PHST- 2014/04/09 06:00 [entrez]
PHST- 2014/04/09 06:00 [pubmed]
PHST- 2015/06/09 06:00 [medline]
AID - 10.1185/03007995.2014.912983 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2014 Jul;30(7):1245-55. doi: 10.1185/03007995.2014.912983. 
      Epub 2014 Apr 29.