PMID- 24597840
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 monotherapy in Japanese patients with type 
      2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.
PG  - 1219-30
LID - 10.1185/03007995.2014.901943 [doi]
AB  - OBJECTIVE: Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for 
      type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was 
      conducted to assess the efficacy and safety of several doses of luseogliflozin in 
      Japanese T2DM patients. PATIENTS AND METHODS: Japanese T2DM patients aged 20-74 
      years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) 
      >/=126 mg/dL and on diet therapy were randomized in a double-blind manner to 
      receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks 
      (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in 
      HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h 
      postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body 
      weight. Drug safety was also assessed. TRIAL REGISTRATION: Japan Pharmaceutical 
      Information Center (identifier: JapicCTI-090908). RESULTS: Changes in HbA1c from 
      baseline to end of treatment were -0.36, -0.62, and -0.75% in the 0.5, 2.5, and 
      5 mg luseogliflozin groups, respectively, versus +0.06% in the placebo group (all 
      P < 0.001). The reductions in FPG and 2 h-PPG in the MTT were also significantly 
      greater in the luseogliflozin groups (all P < 0.01) without increases in insulin 
      levels from baseline. Luseogliflozin reduced body weight at all doses. There were 
      no significant differences in the incidences of adverse events among groups. Most 
      adverse events were mild in severity. There were no serious adverse events. 
      CONCLUSIONS: Although this was a small-scale study with a short duration, all 
      tested doses of luseogliflozin significantly improved glycemic control, reduced 
      body weight, and were well tolerated in Japanese T2DM patients over the 12-week 
      treatment period.
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 - Sakai, Soichi
AU  - Sakai S
FAU - Samukawa, Yoshishige
AU  - Samukawa Y
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140319
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Biomarkers)
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  - Asian People
MH  - Biomarkers/blood
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/ethnology
MH  - Dose-Response Relationship, Drug
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 II clinical study
OT  - Placebo
OT  - Sodium glucose cotransporter 2 (SGLT2) inhibitor
OT  - Type 2 diabetes mellitus
EDAT- 2014/03/07 06:00
MHDA- 2015/06/09 06:00
CRDT- 2014/03/07 06:00
PHST- 2014/03/07 06:00 [entrez]
PHST- 2014/03/07 06:00 [pubmed]
PHST- 2015/06/09 06:00 [medline]
AID - 10.1185/03007995.2014.901943 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2014 Jul;30(7):1219-30. doi: 10.1185/03007995.2014.901943. 
      Epub 2014 Mar 19.