Linagliptin and pioglitazone combination therapy versus monotherapy with linagliptin or pioglitazone: A randomised, double-blind, parallel-group, multinational clinical trial

摘要

Linagliptin plus pioglitazone single-pill combinations were evaluated. Patients (n=936) with insufficient glycaemic control, despite lifestyle interventions, were randomised for 30weeks to either monotherapy with linagliptin 5mg; pioglitazone 15, 30 or 45mg; or single-pill combination with linagliptin 5mg plus pioglitazone 15, 30 or 45mg. An extension (54weeks) planned to evaluate linagliptin plus pioglitazone 30 or 45mg single-pill combinations was not completed due to a protocol amendment. Adjusted mean (95% confidence interval) differences in HbA(1c) change from baseline at week 30 for linagliptin plus pioglitazone 15, 30 and 45mg were -0.17% (-0.41, 0.07), -0.37% (-0.60, -0.14) and -0.41% (-0.64, -0.18) versus pioglitazone monotherapies, respectively, and -0.44% (-0.67, -0.20), -0.68% (-0.91, -0.44) and -0.89% (-1.12, -0.66) versus linagliptin monotherapy, respectively. Single-pill combinations were generally well tolerated. Hypoglycaemia frequency was 1.5% per group. Linagliptin plus pioglitazone combinations were efficacious, with safety profiles comparable to the individual monotherapies.