• Kohei Kaku, Mikiko Mori, Tatsuhiro Kanoo, Masafumi Katou, and Yutaka Seino.
• 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.
• Expert Opin Pharmacother. 2014 Oct 1; 15 (15): 2121-30.

ObjectiveTo 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.Study DesignThis 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.Primary Outcome MeasureChange in glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 12).ResultsThe 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.ConclusionsAlogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM.

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