title: Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: A pooled analysis of three randomized trials.
abstract: This analysis aimed to evaluate efficacy and safety of empagliflozin in combination therapy in <65 y.o. patients, overweight/obese, and with uncontrolled T2DM.
  
  
  
  Pooled analysis from three phase-III trials, in <65 y.o. patients, with BMI 25-35kg/m2, and HbA1c ≥8% at baseline. Patients (N=439) were randomized to placebo (n=138), empagliflozin 10mg (n=160), or empagliflozin 25mg (n=141) once daily (24weeks) as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin.
  
  
  
  At week 24, adjusted mean (SE) changes from baseline in HbA1c were -0.19% (0.07) for placebo vs. -1.10% (0.07) and -1.10% (0.07) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adjusted mean (SE) changes from baseline in weight were -0.33kg (0.21) for placebo vs. -1.94kg (0.19) and -2.14kg (0.20) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adverse events were reported in 57.2% on placebo, 64.4% on empagliflozin 10mg and 59.6% on empagliflozin 25mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10mg, and 5.0% on empagliflozin 25mg.
  
  
  
  In this specific population, empagliflozin in combination with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.
authors: Eli Lilly and Company, Avenida de la Industria, 30, 28108 Alcobendas, Madrid, Spain. Electronic address: romerai@lilly.com.
authors: Irene
authors: I
authors: Romera
authors: Diabetes and Endocrinology Unit, Hospital Clinic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
authors: Ramon
authors: R
authors: Gomis
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Binger Str. 173, 55218 Ingelheim am Rhein, Germany.
authors: Susanne
authors: S
authors: Crowe
authors: Research Institute of Biomedical and Health Sciences (IUIBS), ULPGC. Hospital Universitario de Gran Canaria Dr. Negrín, Barranco de la Ballena, s/n, 35010 Las Palmas de Gran Canaria, Las Palmas, Spain.
authors: Pedro
authors: P
authors: de Pablos-Velasco
authors: Boehringer Ingelheim España, S.A., Carrer de Prat de la Riba, 50, 08174 Sant Cugat del Vallès, Barcelona, Spain.
authors: Unai
authors: U
authors: Aranda
authors: Boehringer Ingelheim España, S.A., Carrer de Prat de la Riba, 50, 08174 Sant Cugat del Vallès, Barcelona, Spain.
authors: Arantxa
authors: A
authors: García
authors: Eli Lilly (Suisse) SA Representative Office, Ulica grada Vukovara 269 G Zgrada V2/8. kat 10000, Zagreb, Croatia.
authors: Sanja Giljanovic
authors: SG
authors: Kis
authors: Eli Lilly and Company, Lilly House, Priestley Rd, Basingstoke RG24 9NL, UK; Faculty of Science, Liverpool Hope University, Hope Park,Liverpool L16 9JD,Reino Unido, Liverpool, UK.
authors: Ebrahim
authors: E
authors: Naderali
mesh_terms: D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005960:Glucosides / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D009765:Obesity / Q000150:complications*; D050177:Overweight / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C570240:empagliflozin
keywords: Glycemic control; Hba1c; Obesity; Oral agents; Therapy; Type 2 diabetes mellitus