title: A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
abstract: OBJECTIVE
  This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Internal Medicine, University of Pisa, Pisa, Italy. ferranni@ifc.cnr.it
authors: E
authors: E
authors: Ferrannini
authors: L
authors: L
authors: Seman
authors: E
authors: E
authors: Seewaldt-Becker
authors: S
authors: S
authors: Hantel
authors: S
authors: S
authors: Pinnetti
authors: H J
authors: HJ
authors: Woerle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001118:Argentina / Q000453:epidemiology; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001786:Blood Glucose; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005060:Europe / Q000453:epidemiology; D005260:Female; D005960:Glucosides / Q000008:administration & dosage* / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced* / Q000453:epidemiology; D056910:Republic of Korea / Q000453:epidemiology; D012426:Russia / Q000453:epidemiology; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013624:Taiwan / Q000453:epidemiology; D013894:Thirst; D016896:Treatment Outcome; D014455:Ukraine / Q000453:epidemiology; D014555:Urination Disorders / Q000139:chemically induced* / Q000453:epidemiology; D015431:Weight Loss
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C517652:hemoglobin A1c protein, human; C570240:empagliflozin
keywords: BI 10773; FPG; HbA1c; SGLT2 inhibitor; body weight; empagliflozin; tolerability