Vildagliptin in drug-naïve patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose study

Horm Metab Res. 2007 Mar;39(3):218-23. doi: 10.1055/s-2007-970422.

Abstract

This 24-week double-blind, randomized, multicenter, placebo-controlled, parallel-group study was performed in 632 drug-naïve patients with type 2 diabetes to assess efficacy and tolerability of vildagliptin (50 mg qd, 50 mg bid, or 100 mg qd). HbA1c decreased modestly in patients receiving placebo (Delta=-0.3+/-0.1%) and to a significantly greater extent in patients receiving vildagliptin 50 mg qd (Delta=-0.8+/-0 .1%), 50 mg bid (Delta=-0.8+/-0.1%), or 100 mg qd (Delta=-0.9+/-0.1%, p<0.01 for all groups VS. placebo) from an average baseline of 8.4%. In patients diagnosed >or=3 months before enrollment, HbA1c increased with placebo (Delta=+0.2+/-0.2%) and between-treatment differences (vildagliptin-placebo) were -0.8+/-0.2% (p<0.001), -0.7+/-0.2% (p=0.003), and -0.9+/-0.2% (p<0.001) with vildagliptin 50 mg qd, 50 mg bid, and 100 mg qd, respectively. There was no apparent dose-response in the overall population; however, in patients with high baseline HbA1c, there were greater reductions with either 100 mg dose regimen (Delta=-1.3+/-0.2% and -1.4+/-0.2%) compared to 50 mg qd (Delta=-0.8+/-0.1%). Body weight decreased modestly in all groups (by 0.3 to 1.8 kg). The incidence of adverse events was similar across all groups and <or=1.2% of patients in any treatment group reported mild hypoglycemia. In conclusion, vildagliptin monotherapy decreases HbA1c in drug-naïve patients without weight gain and is well tolerated with minimal hypoglycemia.

Publication types

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

MeSH terms

  • Adamantane / administration & dosage
  • Adamantane / adverse effects
  • Adamantane / analogs & derivatives*
  • Adamantane / pharmacology
  • Adamantane / therapeutic use
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose
  • Body Weight / drug effects
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Fasting
  • Female
  • Glycated Hemoglobin A
  • Hemoglobins / metabolism
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / pharmacology
  • Hypoglycemic Agents / therapeutic use*
  • Lipids / blood
  • Male
  • Middle Aged
  • Nitriles / administration & dosage*
  • Nitriles / adverse effects
  • Nitriles / pharmacology
  • Nitriles / therapeutic use*
  • Placebos
  • Pyrrolidines / administration & dosage*
  • Pyrrolidines / adverse effects
  • Pyrrolidines / pharmacology
  • Pyrrolidines / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Vildagliptin

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hemoglobins
  • Hypoglycemic Agents
  • Lipids
  • Nitriles
  • Placebos
  • Pyrrolidines
  • hemoglobin A1c protein, human
  • Vildagliptin
  • Adamantane