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.

Study design: 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.

Primary outcome measure: 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.

Keywords::

• alogliptin
• clinical trial
• insulin
• Japanese patients
• type 2 diabetes mellitus

Acknowledgment

This study was supported by Takeda Pharmaceutical Co. Ltd (Osaka, Japan). We acknowledge the assistance of Steve Clissold (ContentEdNet) funded by Takeda, in the preparation of this manuscript. All authors contributed to: i) the conception and design of the study, or acquisition of data or analysis and interpretation of data; ii) drafting the article or revising it critically for important intellectual content; and iii) the final approval of the version submitted. Trial registration: ClinicalTrials.gov identifier NCT01521962.

Notes