The aim of the study was to investigate the long-term safety and efficacy of Empagliflozin ( Jardiance ), a sodium glucose cotransporter 2 inhibitor ( SGLT2 ); Sitagliptin ( Januvia ); and Metformin ( Glucophage ) in patients with type 2 diabetes mellitus.
In this randomized, open-label, 78-week extension study of two 12-week, blinded, dose-finding studies of Empagliflozin ( monotherapy and add-on to Metformin ) with open-label comparators, 272 patients received 10 mg Empagliflozin ( 166 as add-on to Metformin ), 275 received 25 mg Empagliflozin ( 166 as add-on to Metformin ), 56 patients received Metformin, and 56 patients received Sitagliptin as add-on to Metformin.
Changes from baseline in HbA1c at week 90 were -0.34 to -0.63% ( -3.7 to -6.9 mmol/mol ) with Empagliflozin, -0.56% ( -6.1 mmol/mol ) with Metformin, and -0.40% ( -4.4 mmol/mol ) with Sitagliptin.
Changes from baseline in weight at week 90 were -2.2 to -4.0 kg with Empagliflozin, -1.3 kg with Metformin, and -0.4 kg with Sitagliptin.
Adverse events were reported in 63.2-74.1% of patients on Empagliflozin and 69.6% on Metformin or Sitagliptin; most adverse reactions were mild or moderate in intensity.
Hypoglycemic events were rare in all treatment groups, and none required assistance.
Adverse events consistent with genital infections were reported in 3.0-5.5% of patients on Empagliflozin, 1.8% on Metformin, and none on Sitagliptin.
Adverse reactions consistent with urinary tract infections were reported in 3.8-12.7% of patients on Empagliflozin, 3.6% on Metformin, and 12.5% on Sitagliptin.
In conclusion, long-term Empagliflozin treatment has provided sustained glycemic and weight control and was well tolerated with a low risk of hypoglycemia in patients with type 2 diabetes mellitus. ( Xagena )
Ferrannini E et al, Diabetes Care 2013; 36: 4015-4021