Safety and tolerability of combinations of empagliflozin/linagliptin for 52 weeks in patients with type 2 diabetes
S Patel, R De Fronzo, A Lewin, R Kaste, S Kohler, HJ Woerle, UC Broedl · Diabetologie und Stoffwechsel · 2016 · Heft 04
Bibliografische Angaben
Zusammenfassung
Aim: To assess the safety and tolerability of empagliflozin/linagliptin in subjects with type 2 diabetes (T2DM) using pooled Phase III trial data. Methods: Data were pooled from two 52-week Phase III studies in which patients received empagliflozin 25 mg/linagliptin 5 mg (n = 273), empagliflozin 10 mg/linagliptin 5 mg (n = 272), empagliflozin 25 mg (n = 276), empagliflozin 10 mg (n = 275) or linagliptin 5 mg (n = 267) alone or as add-on to metformin. Adverse events (AEs) were assessed descriptively in patients who received ≥1 dose of study drug. Results: Total exposure was 251, 255, 256, 249 and 243 patient-year…