title: Ipragliflozin as an Initial Therapy in Drug Naïve Subjects with Type 2 Diabetes.
abstract: OBJECTIVE
  The aim of this study is to investigate ipragliflozin as an initial type 2 diabetes (T2DM) drug.
  
  
  METHODS
  Ipragliflozin 25-50 mg/day monotherapy was performed with drug naïve subjects with T2DM (n=31). As a comparator, 12.5-25 mg/day alogliptin monotherapy was undertaken (n=32). At 3 months, levels of metabolic parameters were compared with those at baseline.
  
  
  RESULTS
  4 subjects discontinued ipragliflozin due to intolerance or adverse events, while none dropped out with alogliptin. At 3 months, similar decreases of HbA1c levels were observed with these 2 drugs (10.21-8.31%, p<0.00001, with ipragliflozin, and 10.08-8.25%, p<0.00001, with alogliptin), however fasting blood glucose (FBG) levels decreased with significant inter-group differences (- 23.5% with iprgliflozin and - 10.8% with alogliptin). While similar increases of homeostasis model assessment (HOMA)-B levels were observed with these 2 drugs, HOMA-R levels significantly decreased only with ipragliflozin (-19.4%, p<0.02). Un-correlative link between HOMA-R and HOMA-B levels at baseline became significantly correlative (R=0.6017, p<0.001) only with ipragliflozin. Significant reductions of body mass index (BMI, -2.6%, P<0.05) were observed with ipragliflozin, however, no correlations between the changes of BMI and those of HbA1c or FBG were noted.
  
  
  CONCLUSIONS
  These results suggest that ipragliflozin has good glycemic efficacy as an initial therapy in subjects with T2DM, although certain adverse events or tolerability issues are concerned. It improves insulin sensitivity and may restore the impaired beta-cell function. However body weight reduction with ipragliflozin is not associated with its glycemic efficacy.
authors.affiliation: Department of Clinical Research, Biomedical Center, Tokyo, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Kutoh
authors.affiliation: Division of Diabetes and Metabolism, Department of Internal Medicine, Gyoda General Hospital, Saitama, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Wada
authors.affiliation: Department of Clinical Research, Biomedical Center, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Murayama
authors.affiliation: Department of Clinical Research, Biomedical Center, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Hirate
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005960:Glucosides / Q000009:adverse effects / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use; D011446:Prospective Studies; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D014498:Uracil / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010880:Piperidines; D013876:Thiophenes; D014498:Uracil; C572941:ipragliflozin; C520853:alogliptin