title: Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study.
abstract: BACKGROUND
  This study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  Patients (N = 60; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m(2)) were randomized to receive empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19) or placebo (n = 21) once daily as monotherapy for 28 days. A meal tolerance test and continuous glucose monitoring (CGM) for 24 hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast (AUC1-4h for PPG) at day 28.
  
  
  RESULTS
  Adjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were -97.1 (-126.5, -67.8) mg · h/dl with empagliflozin 10 mg and -91.6 (-120.4, -62.8) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -85.5 (-126.0, -45.0) mg · h/dl with empagliflozin 10 mg and -104.9 (-144.8, -65.0) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were -20.8 (-27.0, -14.7) mg/dl with empagliflozin 10 mg and -23.9 (-30.0, -17.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -24.5 (-35.4, -13.6) mg/dl with empagliflozin 10 mg and -31.7 (-42.5,-20.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ≥70 to <180 mg/dl increased from 52.0% at baseline to 77.0% at day 28 with empagliflozin 10 mg and from 55.0% to 81.1% with empagliflozin 25 mg, without increasing time spent with hypoglycemia.
  
  
  CONCLUSIONS
  Empagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01947855.
authors: Jikei University School of Medicine, Tokyo, Japan. rimei.nishimura@gmail.com.
authors: Rimei
authors: R
authors: Nishimura
authors: Nippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. yuko.tanaka@boehringer-ingelheim.com.
authors: Yuko
authors: Y
authors: Tanaka
authors: Nippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. kazuki.koiwai@boehringer-ingelheim.com.
authors: Kazuki
authors: K
authors: Koiwai
authors: EPS Corporation, Tokyo, Japan. kohei.inoue.ext@boehringer-ingelheim.com.
authors: Kohei
authors: K
authors: Inoue
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. thomas.hach@boehringer-ingelheim.com.
authors: Thomas
authors: T
authors: Hach
authors: Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA. afshin.salsali@boehringer-ingelheim.com.
authors: Afshin
authors: A
authors: Salsali
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. soeren.lund@boehringer-ingelheim.com.
authors: Søren S
authors: SS
authors: Lund
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. Uli.Broedl@boehringer-ingelheim.com.
authors: Uli C
authors: UC
authors: Broedl
mesh_terms: D000368:Aged; D044466:Asian People; D001559:Benzhydryl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D005960:Glucosides / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period / Q000187:drug effects / Q000502:physiology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D007004:Hypoglycemic Agents; C570240:empagliflozin
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