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Introduction: Clinical trials of linagliptin in Japanese patients conducted to date have had limited observational periods; therefore, there is a need for additional longer-term real-world data. The aim of this study was to investigate the long-term safety and effectiveness of linagliptin in routine clinical practice. Methods: This was a prospective, observational, post-marketing surveillance study conducted over 156 weeks in patients with type 2 diabetes mellitus who started linagliptin monotherapy. The primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to last available

IntroductionAn estimated 4.3 million people aged ≥ 65 years with diabetes live in Japan. We evaluated the efficacy and safety of linagliptin in older Japanese patients with poorly controlled type 2 diabetes (T2DM).MethodsIn this phase 4, randomised, placebo-controlled national study (part of a global study) conducted in Japan over a period of 52 weeks, 102 patients on stable treatment with basal insulin ± metformin/alpha-glucosidase inhibitors were randomised (1:1) to receive linagliptin 5 mg qd or placebo. The primary end point was the change in glycated haemoglobin (HbA1c) after 24 weeks of treatment, with additional analyses at 52 weeks.ResultsMean age and HbA1c of the study population were 71 years and 8.1%, respectively. Approximately two-thirds of participants were aged ≥ 70 years, two-thirds had macrovascular complications, approximately half had a baseline estimated glomerular filtration rate < 60 ml/min/1.73 m2, and two-thirds had a time since diagnosis of diabetes > 10 years. Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, – 0.71% (95% CI − 0.96, − 0.45, p < 0.0001), and maintained at 52 weeks, – 0.58% (95% CI − 0.82, − 0.34, p < 0.0001). Linagliptin improved the chances of achieving a categorical HbA1c target (< 8.0% and < 7.0%) at 24 and 52 weeks in patients who were not at their respective target at the beginning of the study. Addition of linagliptin to insulin was associated with a numerical increase in the risk of any hypoglycaemia, but not in the risk of clinically significant hypoglycaemia, severe hypoglycaemia or recurring hypoglycaemia.ConclusionLinagliptin was effective in improving glucose control in Japanese patients aged ≥ 60 years with T2DM on stable glucose-lowering therapy with basal insulin. Linagliptin was well tolerated and no new safety concerns were raised. The results presented here are highly consistent with the results from the global study, which was conducted over a 24-week period.Trial RegistrationClinicalTrials.gov identifier, NCT02240680.FundingBoehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01065-7) contains supplementary material, which is available to authorized users.