Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial

Diabetes Obes Metab. 2009 Aug;11(8):804-12. doi: 10.1111/j.1463-1326.2009.01051.x. Epub 2009 May 19.

Abstract

Aims: The study evaluated the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, and metformin in drug-naïve elderly patients with type 2 diabetes. The primary objective was to demonstrate non-inferiority of vildagliptin vs. metformin in glycated haemoglobin (HbA1c) reduction.

Methods: This was a double-blind, randomized, multicentre, active-controlled, parallel-group study of 24-week treatment with vildagliptin (100 mg daily, n=169) or metformin (titrated to 1500 mg daily, n=166) in drug-naïve patients with type 2 diabetes aged>or=65 years (baseline HbA1c 7-9%).

Results: Participants had a mean age of 71 years, known duration of diabetes of 3 years and mean baseline HbA1c of 7.7%. At end-point, vildagliptin was as effective as metformin, improving HbA1c by -0.64+/-0.07% and -0.75+/-0.07%, respectively, meeting the predefined statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference<or=0.3%). Body weight changes were -0.45+/-0.20 kg in vildagliptin-treated patients (p=0.02) and -1.25+/-0.19 kg in metformin-treated patients (p<0.001; p=0.004 vs. vildagliptin). The proportion of patients experiencing an adverse event (AE) was 44.3 vs. 50.3% in patients receiving vildagliptin and metformin respectively. Gastrointestinal (GI) AEs were significantly more frequent with metformin (24.8%) than with vildagliptin (15.0%, p=0.028), mainly driven by a 4.4-fold higher incidence of diarrhoea. A low incidence of hypoglycaemia was observed in both treatment groups (0% with vildagliptin and 1.2% with metformin).

Conclusions: Vildagliptin is an effective and well-tolerated treatment option in elderly patients with type 2 diabetes, demonstrating similar improvement in glycaemic control as metformin, with superior GI tolerability.

Trial registration: ClinicalTrials.gov NCT00246619.

Publication types

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

MeSH terms

  • Adamantane / adverse effects
  • Adamantane / analogs & derivatives*
  • Adamantane / therapeutic use
  • Aged
  • Aged, 80 and over
  • Blood Glucose
  • Body Weight / drug effects
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Dipeptidyl-Peptidase IV Inhibitors / adverse effects
  • Dipeptidyl-Peptidase IV Inhibitors / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Diseases / epidemiology
  • Glycated Hemoglobin A / drug effects
  • Humans
  • Hypoglycemia / epidemiology
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Incidence
  • Male
  • Metformin / adverse effects
  • Metformin / therapeutic use*
  • Nitriles / adverse effects
  • Nitriles / therapeutic use*
  • Pyrrolidines / adverse effects
  • Pyrrolidines / therapeutic use*
  • Vildagliptin

Substances

  • Blood Glucose
  • Dipeptidyl-Peptidase IV Inhibitors
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Nitriles
  • Pyrrolidines
  • Metformin
  • Vildagliptin
  • Adamantane

Associated data

  • ClinicalTrials.gov/NCT00246619