title: Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial.
abstract: OBJECTIVE
  Adjunctive-to-insulin therapy with sodium-glucose cotransporter 2 (SGLT2) inhibition may improve glycemic control in type 1 diabetes (T1D).
  
  
  METHODS
  We evaluated the glycemic efficacy and safety of empagliflozin 25 mg daily in 40 patients treated for 8 weeks in a single-arm open-label proof-of-concept trial (NCT01392560).
  
  
  RESULTS
  Mean A1C decreased from 8.0 ± 0.9% (64 ± 10 mmol/mol) to 7.6 ± 0.9% (60 ± 10 mmol/mol) (P < 0.0001), fasting glucose from 9.0 ± 4.3 to 7.0 ± 3.2 mmol/L (P = 0.008), symptomatic hypoglycemia (<3.0 mmol/L) from 0.12 to 0.04 events per patient per day (P = 0.0004), and daily insulin dose from 54.7 ± 20.4 to 45.8 ± 18.8 units/day (P < 0.0001). Mean urinary excretion of glucose increased from 19 ± 19 to 134 ± 61 g/day (P < 0.0001). Weight decreased from 72.6 ± 12.7 to 70.0 ± 12.3 kg (P < 0.0001), and waist circumference decreased from 82.9 ± 8.7 to 79.1 ± 8.0 cm (P < 0.0001).
  
  
  CONCLUSIONS
  This proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D.
authors.affiliation: Corresponding author: Bruce A. Perkins, bperkins@mtsinai.on.ca.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perkins
authors.forename: David Z I
authors.initials: DZ
authors.lastname: Cherney
authors.forename: Helen
authors.initials: H
authors.lastname: Partridge
authors.forename: Nima
authors.initials: N
authors.lastname: Soleymanlou
authors.forename: Holly
authors.initials: H
authors.lastname: Tschirhart
authors.forename: Bernard
authors.initials: B
authors.lastname: Zinman
authors.forename: Nora M
authors.initials: NM
authors.lastname: Fagan
authors.forename: Stefan
authors.initials: S
authors.lastname: Kaspers
authors.forename: Hans-Juergen
authors.initials: HJ
authors.lastname: Woerle
authors.forename: Uli C
authors.initials: UC
authors.lastname: Broedl
authors.forename: Odd-Erik
authors.initials: OE
authors.lastname: Johansen
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D005960:Glucosides / Q000627:therapeutic use*; D006801:Humans; D007003:Hypoglycemia / Q000175:diagnosis; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D007004:Hypoglycemic Agents; D007328:Insulin; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C570240:empagliflozin