PMID- 29806620
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20220409
IS  - 1348-4540 (Electronic)
IS  - 0918-8959 (Linking)
VI  - 65
IP  - 8
DP  - 2018 Aug 27
TI  - Efficacy and safety of sodium-glucose cotransporter 2 inhibitor ipragliflozin on 
      glycemic control and cardiovascular parameters in Japanese patients with type 2 
      diabetes mellitus; Fukuoka Study of Ipragliflozin (FUSION).
PG  - 859-867
LID - 10.1507/endocrj.EJ18-0022 [doi]
AB  - Sodium-glucose co-transporter-2 inhibitors are newly established anti-diabetic 
      agents with a unique glucose-lowering mechanism. In the present study, we 
      investigated the efficacy and safety of the sodium-glucose co-transporter-2 
      inhibitor ipragliflozin (Ipra) for metabolic markers and cardiovascular 
      parameters in Japanese patients with type 2 diabetes mellitus (T2DM). This study 
      was an investigator-initiated, open-label, single-arm, multicenter prospective 
      study. Patients with T2DM were treated with 50 mg Ipra for 24 and 52 weeks. The 
      primary outcome investigated was the reduction of glycated hemoglobin (HbA1c) 
      level. The secondary outcome was the change in other metabolic and cardiovascular 
      parameters by 24 weeks. Before and after 52 weeks of treatment, carotid 
      intima-media thickening (IMT) was measured by echography. A total of 134 patients 
      were recruited in the study. A 24-week treatment with 50 mg Ipra daily 
      significantly reduced HbA1c level (-0.6%, p < 0.01). Body mass index (BMI), blood 
      pressure and serum C-peptide were reduced significantly (p < 0.05), while serum 
      glucagon level was unchanged. Interestingly, the serum adiponectin and 
      high-density lipoprotein (HDL) cholesterol levels were significantly increased by 
      Ipra. However, 52 weeks of Ipra treatment did not change carotid IMT. Multiple 
      regression analysis revealed that the only significant contributing factor for 
      HbA1c reduction by Ipra was baseline HbA1c level. These data suggest that Ipra 
      decreased not only glucose level but also BMI, blood pressure and serum 
      C-peptide, and the contributing factor for HbA1c reduction by Ipra was baseline 
      HbA1c level. Further, Ipra improved serum adiponectin and HDL cholesterol levels.
FAU - Nomiyama, Takashi
AU  - Nomiyama T
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Shimono, Dai
AU  - Shimono D
AD  - Futata Tetsuhiro Clinic, Fukuoka, Japan.
FAU - Horikawa, Tsuyoshi
AU  - Horikawa T
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Fujimura, Yuki
AU  - Fujimura Y
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Ohsako, Tomohiro
AU  - Ohsako T
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Terawaki, Yuichi
AU  - Terawaki Y
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Fukuda, Takashi
AU  - Fukuda T
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Motonaga, Ryoko
AU  - Motonaga R
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Tanabe, Makito
AU  - Tanabe M
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
FAU - Yanase, Toshihiko
AU  - Yanase T
AD  - Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka 
      University, Fukuoka, Japan.
CN  - Collaborators of Fukuoka Study of Ipragliflozin (FUSION) trial
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180526
PL  - Japan
TA  - Endocr J
JT  - Endocrine journal
JID - 9313485
RN  - 0 (Adiponectin)
RN  - 0 (Blood Glucose)
RN  - 0 (C-Peptide)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Thiophenes)
RN  - 3N2N8OOR7X (ipragliflozin)
SB  - IM
MH  - Adiponectin/blood
MH  - Adult
MH  - Aged
MH  - Blood Glucose
MH  - Body Mass Index
MH  - C-Peptide/blood
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Female
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Sodium-Glucose Transporter 2 Inhibitors/adverse effects/*therapeutic use
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adiponectin
OT  - Baseline hemoglobin A1c
OT  - C-peptide
OT  - High-density lipoprotein cholesterol
OT  - Sodium-glucose co-transporter-2 inhibitor
EDAT- 2018/05/29 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/05/29 06:00
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/05/29 06:00 [entrez]
AID - 10.1507/endocrj.EJ18-0022 [doi]
PST - ppublish
SO  - Endocr J. 2018 Aug 27;65(8):859-867. doi: 10.1507/endocrj.EJ18-0022. Epub 2018 
      May 26.