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

Anja Schweizer, S. Dejager, E. Bosi

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102 Citations (Scopus)

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 (HbA 1c) 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 ≥65 years (baseline HbA 1c 7-9%). Results: Participants had a mean age of 71 years, known duration of diabetes of 3 years and mean baseline HbA 1c of 7.7%. At end-point, vildagliptin was as effective as metformin, improving HbA 1c 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 ≤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.

Original languageEnglish
Pages (from-to)804-812
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number8
DOIs
Publication statusPublished - 2009

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Metformin
Type 2 Diabetes Mellitus
vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Body Weight Changes
Incidence
Glycosylated Hemoglobin A
Therapeutics
Hypoglycemia
Pharmaceutical Preparations
Diarrhea
Confidence Intervals

Keywords

  • Dipeptidyl peptidase 4
  • GLP-1
  • HbA1c
  • Incretin hormones
  • Type 2 diabetes
  • Vildagliptin

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes : A 24-week, double-blind, randomized trial. / Schweizer, Anja; Dejager, S.; Bosi, E.

In: Diabetes, Obesity and Metabolism, Vol. 11, No. 8, 2009, p. 804-812.

Research output: Contribution to journalArticle

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T1 - Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes

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AU - Bosi, E.

PY - 2009

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N2 - 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 (HbA 1c) 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 ≥65 years (baseline HbA 1c 7-9%). Results: Participants had a mean age of 71 years, known duration of diabetes of 3 years and mean baseline HbA 1c of 7.7%. At end-point, vildagliptin was as effective as metformin, improving HbA 1c 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 ≤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.

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