Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study

Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.

Abstract

Aim: To compare continuous glucose monitoring (CGM) profiles on vildagliptin versus sitagliptin in addition to metformin, in patients with inadequately controlled type 2 diabetes mellitus (HbA(1c) 6.5-8.0%).

Methods: A multicenter, prospective, randomised, open-label study with blinded endpoint analysis. CGM data acquired over three days--firstly on metformin alone and then 8 weeks after the addition of either vildagliptin (n=14) or sitagliptin (n=16)--were blinded and analyzed centrally.

Results: In comparable populations with a mean baseline HbA1c of 7.1%, 24-hour glucose variability--measured by mean amplitude of glucose excursions and standard deviation of mean glucose concentration--showed similar improvement on both drugs versus metformin alone. In contrast, a series of predefined parameters reflecting daily glycaemic control--mean 24-hour blood glucose concentration, and the times spent in the optimal glycaemic range (70-140 mg/dL) and above the hyperglycaemic thresholds of 140 and 180 mg/dL together with the corresponding AUC values--were significantly improved from baseline only in the vildagliptin arm. In addition, overall hyperglycaemia (AUC[24 h] > 100 mg/dL) significantly dropped from baseline on vildagliptin [-37%] but not on sitagliptin [-9%], while postprandial hyperglycaemia (AUC[0-4 h] × 3) was significantly reduced on both, and basal hyperglycaemia (overall--postprandial hyperglycaemia was reduced only on vildagliptin [-41%; P = 0.04]).

Conclusions: The addition of a DPP-4 inhibitor significantly reduced glycaemic variability with no difference between the two drugs. However, vildagliptin induced better circadian glycaemic control than sitagliptin with a significant decrease on overall hyperglycemia, mainly driven by reduction on basal hyperglycaemia.

Trial registration: ClinicalTrials.gov NCT01193296.

Publication types

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

MeSH terms

  • Adamantane / administration & dosage
  • Adamantane / analogs & derivatives*
  • Adamantane / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • Blood Glucose Self-Monitoring / instrumentation
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Dipeptidyl-Peptidase IV Inhibitors / administration & dosage
  • Dipeptidyl-Peptidase IV Inhibitors / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • France / epidemiology
  • Humans
  • Hyperglycemia / blood
  • Hyperglycemia / drug therapy*
  • Hyperglycemia / epidemiology
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Metformin / administration & dosage
  • Metformin / therapeutic use*
  • Middle Aged
  • Nitriles / administration & dosage
  • Nitriles / therapeutic use*
  • Pilot Projects
  • Prospective Studies
  • Pyrazines / administration & dosage
  • Pyrazines / therapeutic use*
  • Pyrrolidines / administration & dosage
  • Pyrrolidines / therapeutic use*
  • Sitagliptin Phosphate
  • Treatment Outcome
  • Triazoles / administration & dosage
  • Triazoles / therapeutic use*
  • Vildagliptin
  • Young Adult

Substances

  • Blood Glucose
  • Dipeptidyl-Peptidase IV Inhibitors
  • Hypoglycemic Agents
  • Nitriles
  • Pyrazines
  • Pyrrolidines
  • Triazoles
  • Metformin
  • Vildagliptin
  • Adamantane
  • Sitagliptin Phosphate

Associated data

  • ClinicalTrials.gov/NCT01193296