Safety and tolerability of combinations of empagliflozin/linagliptin for 52 weeks in patients with type 2 diabetes

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-years in the empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg and linagliptin 5 mg groups, respectively. The percentage of patients with any AE(s) was 73.6%, 71.0%, 71.0, 74.9% and 70.4% in the empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg and linagliptin 5 mg groups, respectively, with confirmed hypoglycaemic AEs (plasma glucose ≤70 mg/dl and/or requiring assistance) was 1.8%, 1.1%, 2.2%, 2.2% and 1.5%, respectively (none required assistance), with events consistent with urinary tract infection (based on 70 preferred terms [PTs]) was 11.4%, 12.5%, 12.0%, 13.8% and 12.7%, respectively, and with events consistent with genital infection (based on 89 PTs) was 4.0%, 4.4%, 6.5%, 6.5% and 2.6%, respectively.

Conclusion: Empagliflozin/linagliptin alone or as add-on to metformin for 52 weeks was well tolerated in subjects with T2DM, with safety profiles similar to individual components.