title: Empagliflozin as add-on to metformin in people with Type 2 diabetes.
abstract: OBJECTIVE
  To investigate the long-term efficacy and safety of empagliflozin as add-on to metformin in people with Type 2 diabetes.
  
  
  METHODS
  Of 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double-blind extension trial for ≥ 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA1c , weight and blood pressure at week 76.
  
  
  RESULTS
  Compared with placebo, adjusted mean changes from baseline in HbA1c (overall baseline mean ± sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were -7 mmol/mol [(-0.6%) 95% CI -8, -5 mmol/mol (-0.8, -0.5%); P < 0.001] and -8 mmol/mol [(-0.7%) 95% CI -10, -6 mmol/mol (-0.9, -0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were -1.9 kg (95% CI -2.5, -1.3; P < 0.001) and -2.2 kg (95% CI -2.8, -1.6; P < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose ≤ 3.9 mmol/l and/or event requiring assistance) were reported in 3.4, 4.1 and 4.2% of participants in these groups, respectively.
  
  
  CONCLUSIONS
  In people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add-on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA1c , weight and systolic blood pressure.
authors.affiliation: Diabetes- und Nierenzentrum, Dormagen, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Merker
authors.affiliation: University of Tübingen, Tübingen, Germany.
authors.forename: H-U
authors.initials: HU
authors.lastname: Häring
authors.affiliation: Boehringer Ingelheim Danmark A/S, Copenhagen, Denmark.
authors.forename: A V
authors.initials: AV
authors.lastname: Christiansen
authors.affiliation: Boehringer Ingelheim France S.A.S., Reims, France.
authors.forename: F
authors.initials: F
authors.lastname: Roux
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
authors.forename: A
authors.initials: A
authors.lastname: Salsali
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Kim
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Meinicke
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: H J
authors.initials: HJ
authors.lastname: Woerle
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: U C
authors.initials: UC
authors.lastname: Broedl
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003927:Diet, Diabetic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004351:Drug Resistance; D004359:Drug Therapy, Combination / Q000009:adverse effects; D015444:Exercise; D005260:Female; D005960:Glucosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D006973:Hypertension / Q000150:complications / Q000517:prevention & control / Q000628:therapy; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D049990:Membrane Transport Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D050177:Overweight / Q000150:complications / Q000517:prevention & control / Q000628:therapy; D000077203:Sodium-Glucose Transporter 2 Inhibitors
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; D049990:Membrane Transport Modulators; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D008687:Metformin; C570240:empagliflozin