Diabetologie und Stoffwechsel 2014; 9 - P138
DOI: 10.1055/s-0034-1374995

Baseline characteristics of participants enrolled in the empagliflozin cardiovascular outcome trial (EMPA-REG OUTCOME™) in patients with type 2 diabetes

B Zinman 1, 2, S Inzucchi 3, J Lachin 4, C Wanner 5, R Ferrari 6, D Fitchett 7, E Bluhmki 8, J Kempthorne-Rawson 9, J Newman 9, OE Johansen 10, HJ Woerle 11, UC Broedl 11
  • 1Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada
  • 2Division of Endocrinology, University of Toronto, Toronto, Canada
  • 3Section of Endocrinology, Yale University School of Medicine, New Haven, United States
  • 4The Biostatistics Center, The George Washington University, Rockville, United States
  • 5Department of Medicine, Division of Nephrology, University Clinic, Würzburg, Germany
  • 6Section of Cardiology, University of Ferrara, Ferrara, Italy
  • 7St Michaels Hospital, University of Toronto, Toronto, Canada
  • 8Boehringer Ingelheim, Biberach, Germany
  • 9Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, United States
  • 10Boehringer Ingelheim, Asker, Norway
  • 11Boehringer Ingelheim, Ingelheim, Germany

Background, material and methods: The EMPA-REG OUTCOME™ trial (NCT01131676) will investigate the effect of the sodium glucose cotransporter 2 inhibitor empagliflozin 10 mg or 25 mg od compared with placebo, upon a background of optimal standard of care, on cardiovascular (CV) outcomes in patients with type 2 diabetes mellitus (T2DM) at increased CV risk. The study is a double-blind, double-dummy and event-driven (691 CV deaths, non-fatal myocardial infarctions or non-fatal strokes) trial, powered for CV non-inferiority and superiority.

Results: Between September 2010 and April 2013, 7063 patients were randomised at 594 sites. Most participants were recruited from Europe (41%), North America (20%) or Asia (19%), 29% were women, mean (SD) age was 63 (9) years (9% of patients were ≥75 years of age) and mean (SD) HbA1c was 8.1 (0.8)% (49% of patients had HbA1c < 8.0%). Diabetes duration was ≤5 years in 18% of patients and > 10 years in 57%. Most patients (99%) had previous CV complications. Most patients had mild (estimated glomerular filtration rate [eGFR] 60 – 90 ml/min/1.73 m2; 52%) or moderate (eGFR 30 – 60 ml/min/1.73 m2; 26%) renal impairment, and 40% had albuminuria.

Conclusion: Baseline characteristics of participants enrolled in this trial indicate that they are at high CV risk, as anticipated. We expect the results of the EMPA-REG OUTCOME™ trial to answer the hypothesis that empagliflozin is safe or even protective from a CV standpoint, given its glucose-, weight-, and blood pressure-lowering properties. This trial may further inform clinical decision-making for selecting glucose lowering therapy for patients with T2DM.