title: Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): crossover pilot study (J-VICTORIA study).
abstract: BACKGROUND
  No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM) and cardiovascular parameters.
  
  
  METHODS
  Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1) mean (± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) fasting blood glucose level, 4) highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) area under the curve (AUC) for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7) area over the curve (AOC) for daily blood glucose level <70 mg/dL. Plasma glycosylated hemoglobin (HbA1c), glycoalbumin (GA), 1,5-anhydroglucitol (1,5AG), immunoreactive insulin (IRI), C-peptide immunoreactivity (CPR), brain natriuretic peptide (BNP), and plasminogen activator inhibitor-1 (PAI-1) levels, and urinary CPR levels, were measured.
  
  
  RESULTS
  The mean 24-hour blood glucose level was significantly lower in patients taking vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012). In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040), the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015), the AUC (≥180 mg/dL) within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025), and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008) than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin.
  
  
  CONCLUSIONS
  CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin.
  
  
  BACKGROUND
  UMIN000007687.
authors.affiliation: Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan. m-sakamoto@umin.ac.jp
authors.forename: Masaya
authors.initials: M
authors.lastname: Sakamoto
authors.forename: Rimei
authors.initials: R
authors.lastname: Nishimura
authors.forename: Taiga
authors.initials: T
authors.lastname: Irako
authors.forename: Daisuke
authors.initials: D
authors.lastname: Tsujino
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Ando
authors.forename: Kazunori
authors.initials: K
authors.lastname: Utsunomiya
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood / Q000652:urine; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002096:C-Peptide / Q000097:blood / Q000652:urine; D018592:Cross-Over Studies; D003847:Deoxyglucose / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D017127:Glycation End Products, Advanced; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D020097:Natriuretic Peptide, Brain / Q000097:blood; D009570:Nitriles / Q000008:administration & dosage*; D010865:Pilot Projects; D017395:Plasminogen Activator Inhibitor 1 / Q000097:blood; D019518:Postprandial Period; D011237:Predictive Value of Tests; D011719:Pyrazines / Q000008:administration & dosage*; D011759:Pyrrolidines / Q000008:administration & dosage*; D012709:Serum Albumin / Q000378:metabolism; D000068900:Sitagliptin Phosphate; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*; D000077597:Vildagliptin; D000093423:Glycated Serum Albumin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D001786:Blood Glucose; D002096:C-Peptide; D003847:Deoxyglucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D017127:Glycation End Products, Advanced; D020097:Natriuretic Peptide, Brain; D009570:Nitriles; D017395:Plasminogen Activator Inhibitor 1; D011719:Pyrazines; D011759:Pyrrolidines; D012709:Serum Albumin; D000068900:Sitagliptin Phosphate; D014230:Triazoles; D000077597:Vildagliptin; D000093423:Glycated Serum Albumin; C051321:SERPINE1 protein, human; C517652:hemoglobin A1c protein, human; C006584:1,5-anhydroglucitol