Long-Term Safety and Efficacy of Empagliflozin, Sitagliptin, and Metformin

• DOI: 10.2337/dc13-0663
• Publication Date: 2013-11-02T02:17:21Z
• Authors: Ele Ferrannini; Andreas Berk; Stefan Hantel; Sabine Pinnetti; Thomas Hach; Hans J. Woerle; Uli C. Broedl
• Keywords: Empagliflozin

To investigate the long-term safety and efficacy of empagliflozin, a sodium glucose cotransporter 2 inhibitor; sitagliptin; metformin in patients with type diabetes.In this randomized, open-label, 78-week extension study two 12-week, blinded, dose-finding studies empagliflozin (monotherapy add-on to metformin) open-label comparators, 272 received 10 mg (166 as metformin), 275 25 56 metformin, sitagliptin metformin.Changes from baseline HbA1c at week 90 were -0.34 -0.63% (-3.7 -6.9 mmol/mol) -0.56% (-6.1 -0.40% (-4.4 sitagliptin. Changes weight -2.2 -4.0 kg -1.3 -0.4 Adverse events (AEs) reported 63.2-74.1% on 69.6% or most AEs mild moderate intensity. Hypoglycemic rare all treatment groups, none required assistance. consistent genital infections 3.0-5.5% 1.8% urinary tract 3.8-12.7% 3.6% 12.5% sitagliptin.Long-term provided sustained glycemic control was well tolerated low risk hypoglycemia diabetes.