title: Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes mellitus (T2DM) who are poorly controlled with insulin and diet or exercise.
  
  
  METHODS
  This was a randomized, double-blind, 12-week comparative trial of alogliptin and insulin versus placebo and insulin in 179 patients with T2DM followed by a 40-week, open-label phase in 169 patients on alogliptin and insulin.
  
  
  METHODS
  Change in glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 12).
  
  
  RESULTS
  The change in HbA1c (least squares means) from baseline to week 12 was -0.96% for the alogliptin and insulin group and -0.29% for the placebo and insulin group. The point estimate (95% confidence interval) intergroup difference was -0.66% ([-0.824%, -0.503%]). In the alogliptin and insulin group, HbA1c started to decrease from week 2 onward and peaked by week 12. The proportions of patients who achieved HbA1c < 8.0, < 7.0 and < 6.0% at week 12 were significantly higher in alogliptin and insulin group (73.0, 23.3 and 1.1%) than in placebo and insulin group (25.0, 5.7 and 0%). Incidences of adverse effects were comparable between groups, with no relevant increases in hypoglycemia or weight gain seen.
  
  
  CONCLUSIONS
  Alogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM.
authors.affiliation: Kawasaki Medical School , 577, Matsushima, Kurashiki-shi, Okayama 701-0192 , Japan +81 86 462 1111 ; +81 86 462 1199 ; kka@med.kawasaki-m.ac.jp.
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
authors.forename: Mikiko
authors.initials: M
authors.lastname: Mori
authors.forename: Tatsuhiro
authors.initials: T
authors.lastname: Kanoo
authors.forename: Masafumi
authors.initials: M
authors.lastname: Katou
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use; D015990:Placebo Effect; D014498:Uracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015430:Weight Gain / Q000187:drug effects
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010880:Piperidines; D014498:Uracil; C517652:hemoglobin A1c protein, human; C520853:alogliptin
keywords: Japanese patients; alogliptin; clinical trial; insulin; type 2 diabetes mellitus