ABSTRACT
Objective To evaluate the efficacy and safety of dipeptidyl peptidase-4 inhibitor,linagliptin,in subjects aged 60 years or older with type 2 diabetes mellitus (T2DM).Methods Data from eight 24-week,multinational,multicenter,randomized,double-blind,placebo-controlled,parallel-group studies were analyzed.Patients aged 60 years or older with T2DM were received oral linagliptin (5 mg/d) or placebo in combination with mefformin,or metformin plus sulfonylurea.Efficacy was assessed by the changes in glycosylated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment.Safety endpoint included the frequency and intensity of adverse events.Results A total of 1 421 patients (placebo 429,linagliptin 992) were included in the full analysis set (FAS).Mean ages of the subjects were (67.4 ± 5.6) years in the linagliptin group and (66.7-± 5.6) years in the placebo group.Baseline HbA1c was (8.0 ±0.8) ％ in the linagliptin group and (8.1 ±0.9) ％ in the placebo group.At the end of 24-week,placebo-adjusted reduction in HbAlc in subjects with linagliptin was (0.7 ±0.1)％ (95％ CI 0.6-0.8,P ＜0.000 1),and placebo-adjusted reduction in FPG in subjects with linagliptin was (0.88 ±0.12) mmol/L(95％ CI 0.65-1.11,P ＜0.000 1).Overall safety and tolerability in the two groups were similar.Adverse events occurred in 57.1％ of patients in the placebo group and 61.1％ of patients in the linagliptin group,and the incidence of adverse events leading to discontinuation was 3.2％ in the placebo group and 3.8％ in the linagliptin group.Serious adverse events occurred in 1.6％ of patients in the placebo group and 2.8％ of patients in the linagliptin group.Investigator-defined hypoglycaemia occurred in 7.3％ of patients in the placebo group and 11.9％ of patients in the linagliptin group.Among them,most were mild or moderate hypoglycaemia,and severe hypoglycaemia only occurred in 0.2％ of patients in the placebo and 0.5％ in the linagliptin groups.Overall incidence of hypoglycaemia in linagliptin group was slightly higher than that in placebo group,which might be due to the fact that more patients were taking sulfonylureas in linagliptin group than in placebo group (26.8％ linagliptin;18.4％ placebo).No difference could be viewed in hypoglycaemia between the two groups in patients without sulfonylureas (1.2％ linagliptin,1.1％ placebo)Moreover,no severe hypoglycaemia was reported in subjects without sulfonylureas.The incidences of other adverse events were similar in both groups.Conclusion Linagliptin was efficacious in lowering glucose with a safety profile similar to placebo in type 2 diabetic patients aged 60 years or older.