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. (October 2014)

• Record Type: Journal Article
• Authors: Kaku, Kohei; Mori, Mikiko; Kanoo, Tatsuhiro; Katou, Masafumi; Seino, Yutaka
• Is Part Of: Expert opinion on pharmacotherapy. Volume 15:Number 15(2014)
• Page Start: 2121
• Page End: 2130
• Publication Date: 2014-10
• Subjects: Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1517/14656566.2014.956722
• Languages: English
• ISSNs: 1465-6566

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objective:</italic> </bold> 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.</p> <p> <bold> <italic>Study design:</italic> </bold> 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.</p> <p> <bold> <italic>Primary outcome measure:</italic> </bold> Change in glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 12).</p> <p> <bold> <italic>Results:</italic> </bold> 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.</p> <p> <bold> <italic>Conclusions:</italic> </bold> Alogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM.</p> </abstract>