A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes
Article first published online: 4 MAR 2013
© 2013 Blackwell Publishing Ltd
Diabetes, Obesity and Metabolism
Volume 15, Issue 8, pages 721–728, August 2013
How to Cite
Ferrannini, E., Seman, L., Seewaldt-Becker, E., Hantel, S., Pinnetti, S. and Woerle, H. J. (2013), A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. Diabetes, Obesity and Metabolism, 15: 721–728. doi: 10.1111/dom.12081
- Issue published online: 1 JUL 2013
- Article first published online: 4 MAR 2013
- Accepted manuscript online: 8 FEB 2013 02:02PM EST
- Manuscript Accepted: 4 FEB 2013
- Manuscript Revised: 28 DEC 2012
- Manuscript Received: 3 DEC 2012
- Boehringer Ingelheim
- BI 10773;
- SGLT2 inhibitor;
- body weight;
This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
Four hundred and eight patients (treatment-naïve or after a 4-week wash-out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open-label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.
After 12 weeks' treatment, empagliflozin showed dose-dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: −1.29 mmol/l, 10 mg: −1.61 mmol/l, 25 mg: −1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation.
In patients with type 2 diabetes, empagliflozin resulted in dose-dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well-tolerated with a favourable safety profile.