Empagliflozin As Add-on to Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes
A 24-week, randomized, double-blind, placebo-controlled trial
- Hans-Ulrich Häring, MD1⇑,
- Ludwig Merker, MD2,
- Elke Seewaldt-Becker, PHD3,
- Marc Weimer, PHD3,
- Thomas Meinicke, MD3,
- Hans J. Woerle, MD4,
- Uli C. Broedl, MD4,
- on behalf of the EMPA-REG METSU™ Trial Investigators
- 1University of Tübingen, Tübingen, Germany
- 2Diabetes-und Nierenzentrum Center, Dormagen, Germany
- 3Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
- 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
- Corresponding author: Hans-Ulrich Häring, .
H.-U.H. and L.M. contributed equally to this study.
OBJECTIVE To investigate the efficacy and tolerability of empagliflozin as add-on to metformin and sulfonylurea in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS Patients inadequately controlled on metformin and sulfonylurea (HbA1c ≥7 to ≤10%) were randomized and treated with once-daily empagliflozin 10 mg (n = 225), empagliflozin 25 mg (n = 216), or placebo (n = 225) for 24 weeks. The primary end point was change from baseline in HbA1c at week 24. Key secondary end points were changes from baseline in weight and mean daily glucose (MDG) at week 24.
RESULTS At week 24, adjusted mean (SE) changes from baseline in HbA1c were −0.17% (0.05) for placebo vs. −0.82% (0.05) and −0.77% (0.05) for empagliflozin 10 and 25 mg, respectively (both P < 0.001). Empagliflozin significantly reduced MDG, weight, and systolic (but not diastolic) blood pressure versus placebo. Adverse events were reported in 62.7, 67.9, and 64.1% of patients on placebo and empagliflozin 10 and 25 mg, respectively. Events consistent with urinary tract infection were reported in 8.0, 10.3, and 8.3% of patients on placebo and empagliflozin 10 and 25 mg, respectively (females: 13.3, 18.0, and 17.5%, respectively; males: 2.7, 2.7, and 0%, respectively). Events consistent with genital infection were reported in 0.9, 2.7, and 2.3% of patients on placebo and empagliflozin 10 and 25 mg, respectively (females: 0.9, 4.5, and 3.9%, respectively; males: 0.9% in each group).
CONCLUSIONS Empagliflozin 10 and 25 mg for 24 weeks as add-on to metformin plus sulfonylurea improved glycemic control, weight, and systolic blood pressure and were well tolerated.
- Received December 21, 2012.
- Accepted May 5, 2013.
- © 2013 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.