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

• Published in: Expert opinion on pharmacotherapy Vol. 15; no. 15; p. 2121
• Main Authors: Kaku, Kohei, Mori, Mikiko, Kanoo, Tatsuhiro, Katou, Masafumi, Seino, Yutaka
• Format: Journal Article
• Language: English
• Published: England 01.10.2014
• Subjects: Aged; Blood Glucose - analysis; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; Double-Blind Method; Drug Therapy, Combination; Female; Glycated Hemoglobin A - analysis; Humans; Hypoglycemia - chemically induced; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin - adverse effects; Insulin - therapeutic use; Japan - epidemiology; Male; Middle Aged; Piperidines - adverse effects; Piperidines - therapeutic use; Placebo Effect; Uracil - adverse effects; Uracil - analogs & derivatives; Uracil - therapeutic use; Weight Gain - drug effects; clinical trial; type 2 diabetes mellitus; Japanese patients; insulin; alogliptin
• ISSN: 1744-7666
• DOI: 10.1517/14656566.2014.956722

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. 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. Change in glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 12). 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. Alogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM.