Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): crossover pilot study (J-VICTORIA study)

Cardiovasc Diabetol. 2012 Aug 6:11:92. doi: 10.1186/1475-2840-11-92.

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.

Trial registration: UMIN000007687.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adamantane / administration & dosage
  • Adamantane / analogs & derivatives*
  • Adult
  • Aged
  • Biomarkers / blood
  • Biomarkers / urine
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • C-Peptide / blood
  • C-Peptide / urine
  • Cross-Over Studies
  • Deoxyglucose / blood
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Dipeptidyl-Peptidase IV Inhibitors / administration & dosage*
  • Drug Administration Schedule
  • Female
  • Glycated Hemoglobin / metabolism
  • Glycated Serum Albumin
  • Glycation End Products, Advanced
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Monitoring, Ambulatory*
  • Natriuretic Peptide, Brain / blood
  • Nitriles / administration & dosage*
  • Pilot Projects
  • Plasminogen Activator Inhibitor 1 / blood
  • Postprandial Period
  • Predictive Value of Tests
  • Pyrazines / administration & dosage*
  • Pyrrolidines / administration & dosage*
  • Serum Albumin / metabolism
  • Sitagliptin Phosphate
  • Time Factors
  • Treatment Outcome
  • Triazoles / administration & dosage*
  • Vildagliptin

Substances

  • Biomarkers
  • Blood Glucose
  • C-Peptide
  • Dipeptidyl-Peptidase IV Inhibitors
  • Glycated Hemoglobin A
  • Glycation End Products, Advanced
  • Nitriles
  • Plasminogen Activator Inhibitor 1
  • Pyrazines
  • Pyrrolidines
  • SERPINE1 protein, human
  • Serum Albumin
  • Triazoles
  • hemoglobin A1c protein, human
  • Natriuretic Peptide, Brain
  • 1,5-anhydroglucitol
  • Deoxyglucose
  • Vildagliptin
  • Adamantane
  • Sitagliptin Phosphate
  • Glycated Serum Albumin