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

AbstractAIMS:
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.
AuthorsA Schweizer, S Dejager, E Bosi
JournalDiabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 11 Issue 8 Pg. 804-12 (Aug 2009) ISSN: 1463-1326 [Electronic] England
PMID19476473 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Blood Glucose
  • Dipeptidyl-Peptidase IV Inhibitors
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Nitriles
  • Pyrrolidines
  • Metformin
  • Vildagliptin
  • Adamantane
Topics
  • Adamantane (adverse effects, analogs & derivatives, 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, therapeutic use)
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Diseases (epidemiology)
  • Glycated Hemoglobin (drug effects)
  • Humans
  • Hypoglycemia (epidemiology)
  • Hypoglycemic Agents (adverse effects, therapeutic use)
  • Incidence
  • Male
  • Metformin (adverse effects, therapeutic use)
  • Nitriles (adverse effects, therapeutic use)
  • Pyrrolidines (adverse effects, therapeutic use)
  • Vildagliptin

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