PMID- 29926400
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 9
IP  - 4
DP  - 2018 Aug
TI  - Ipragliflozin Add-on Therapy to a GLP-1 Receptor Agonist in Japanese Patients 
      with Type 2 Diabetes (AGATE): A 52-Week Open-Label Study.
PG  - 1549-1567
LID - 10.1007/s13300-018-0455-8 [doi]
AB  - INTRODUCTION: Few data are available regarding ipragliflozin treatment in 
      combination with glucagon-like peptide-1 (GLP-1) receptor agonists. The aim of 
      this study was to evaluate the efficacy and safety of ipragliflozin in 
      combination with GLP-1 receptor agonists in Japanese patients with inadequately 
      controlled type 2 diabetes mellitus (T2DM). METHODS: This multicenter study 
      (consisting of three periods: a 4-week washout period, a 6-week observation 
      period, and a 52-week open-label treatment period) included patients aged 
      >/= 20 years who received a stable dose/regimen of a GLP-1 receptor agonist either 
      solely or in combination therapy with a sulfonylurea for >/= 6 weeks, with 
      glycosylated hemoglobin (HbA1c) of >/= 7.5% and a fasting plasma glucose (FPG) 
      of >/= 126 mg/dL. Ipragliflozin treatment was given at a fixed dose of 50 mg/day 
      for 20 weeks, followed by 50 or 100 mg/day for 32 weeks. Changes from baseline in 
      glycemic control and other parameters were examined; safety was also assessed. 
      RESULTS: The mean changes in HbA1c and body weight from baseline to end of 
      treatment were - 0.92% and - 2.69 kg, respectively, in all ipragliflozin-treated 
      patients (n = 103). Overall, sustained reductions from baseline were observed for 
      HbA1c, FPG, self-monitored blood glucose, and body weight during the 52-week 
      treatment. The dose increase of ipragliflozin to 100 mg/day resulted in better 
      glycemic control and weight reduction for patients in whom the 50-mg dose was 
      insufficient. Overall, 46.6% (48/103) of patients experienced drug-related 
      adverse events. The most common drug-related treatment-emergent adverse events 
      were pollakiuria (9.7%), hypoglycemia (8.7%), constipation (6.8%), and thirst 
      (5.8%). CONCLUSION: Combined therapy with ipragliflozin and GLP-1 receptor 
      agonists/sulfonylureas was significantly efficacious in reducing glycemic 
      parameters in patients with T2DM with inadequate glycemic control, and no major 
      safety concerns were identified. The results from this study suggest that 
      ipragliflozin can be recommended as a well-tolerated and effective add-on therapy 
      to a GLP-1 receptor agonist for the treatment of T2DM. TRIAL REGISTRATION: 
      ClinicalTrials.gov (identifier: NCT02291874). FUNDING: Astellas Pharma Inc., 
      Tokyo, Japan.
FAU - Ishihara, Hisamitsu
AU  - Ishihara H
AD  - Division of Diabetes and Metabolic Diseases, Nihon University School of Medicine, 
      30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan. 
      ishihara.hisamitsu@nihon-u.ac.jp.
FAU - Yamaguchi, Susumu
AU  - Yamaguchi S
AD  - Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho Chuo-ku, Tokyo, 103-8411, Japan.
FAU - Nakao, Ikko
AU  - Nakao I
AD  - Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho Chuo-ku, Tokyo, 103-8411, Japan.
FAU - Sakatani, Taishi
AU  - Sakatani T
AD  - Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho Chuo-ku, Tokyo, 103-8411, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02291874
PT  - Journal Article
DEP - 20180620
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC6064587
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Glucagon-like peptide-1 receptor
OT  - Ipragliflozin
OT  - Sodium-glucose cotransporter 2
EDAT- 2018/06/22 06:00
MHDA- 2018/06/22 06:01
PMCR- 2018/06/20
CRDT- 2018/06/22 06:00
PHST- 2018/02/13 00:00 [received]
PHST- 2018/06/22 06:00 [pubmed]
PHST- 2018/06/22 06:01 [medline]
PHST- 2018/06/22 06:00 [entrez]
PHST- 2018/06/20 00:00 [pmc-release]
AID - 10.1007/s13300-018-0455-8 [pii]
AID - 455 [pii]
AID - 10.1007/s13300-018-0455-8 [doi]
PST - ppublish
SO  - Diabetes Ther. 2018 Aug;9(4):1549-1567. doi: 10.1007/s13300-018-0455-8. Epub 2018 
      Jun 20.