title: Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, with the alpha glucosidase inhibitor, acarbose, in drug-naive patients with Type 2 diabetes.
  
  
  METHODS
  This multi-centre, randomized, double-blind, parallel-arm study compared the efficacy and tolerability of vildagliptin (100 mg daily, given as 50 mg twice daily, n = 441) and acarbose (up to 300 mg daily, given as three equally divided doses, n = 220) during 24-week treatment in drug-naive patients with Type 2 diabetes.
  
  
  RESULTS
  Monotherapy with vildagliptin or acarbose decreased glycated haemoglobin (HbA(1c)) (baseline approximately 8.6%) to a similar extent during 24-week treatment. The adjusted mean change from baseline to end-point (AMDelta) in HbA(1c) was -1.4 +/- 0.1% and -1.3 +/- 0.1% in patients receiving vildagliptin and acarbose, respectively, meeting the statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference < or = 0.4%). The decrease in fasting plasma glucose was similar with acarbose (-1.5 +/- 0.2 mmol/l) and vildagliptin (-1.2 +/- 0.1 mmol/l). Body weight did not change in vildagliptin-treated patients (-0.4 +/- 0.1 kg) but decreased in acarbose-treated patients (-1.7 +/- 0.2 kg, P < 0.001 vs. vildagliptin). The proportion of patients experiencing any adverse event (AE) was 35% vs. 51% in patients receiving vildagliptin or acarbose, respectively; gastrointestinal AEs were significantly more frequent with acarbose (25.5%) than vildagliptin (12.3%, P < 0.001). No hypoglycaemia was reported for either group.
  
  
  CONCLUSIONS
  Vildagliptin is effective and well tolerated in patients with Type 2 diabetes, demonstrating similar glycaemic reductions to acarbose, but with better tolerability.
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: C
authors.initials: C
authors.lastname: Pan
authors.forename: W
authors.initials: W
authors.lastname: Yang
authors.forename: J P
authors.initials: JP
authors.lastname: Barona
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: M
authors.initials: M
authors.lastname: Niggli
authors.forename: P
authors.initials: P
authors.lastname: Mohideen
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: J E
authors.initials: JE
authors.lastname: Foley
mesh_terms: D020909:Acarbose / Q000008:administration & dosage* / Q000009:adverse effects; D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; D000218:Adamantane; D020909:Acarbose