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A comparison of efficacy and safety of vildagliptin and gliclazide in combination with metformin in patients with Type 2 diabetes inadequately controlled with metformin alone: a 52‐week, randomized study
Author(s) -
Filozof C.,
Gautier J.F.
Publication year - 2010
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2010.02938.x
Subject(s) - vildagliptin , gliclazide , medicine , metformin , type 2 diabetes , diabetes mellitus , adverse effect , randomized controlled trial , gastroenterology , clinical endpoint , endocrinology
Diabet. Med. 27, 318–326 (2010) Abstract Aim To demonstrate non‐inferiority of vildagliptin compared with gliclazide, as an add‐on therapy, in patients with Type 2 diabetes inadequately controlled with metformin in a 52‐week, randomized, double‐blind, active‐controlled study. Methods Patients receiving a stable dose of metformin (≥ 1500 mg) were randomized (1 : 1) to receive vildagliptin (50 mg twice daily; n = 513) or gliclazide (up to 320 mg/day; n = 494). Results Non‐inferiority of vildagliptin was demonstrated (95% confidence interval −0.11%, 0.20%) with a mean change ( se ) from baseline glycated haemoglobin (HbA 1c ) (∼ 8.5% in both groups) to a 52‐week endpoint of −0.81% (0.06) with vildagliptin and −0.85% (0.06) with gliclazide. Although a similar proportion of patients reached HbA 1c < 7.0%, the total number of hypoglycaemic events was lower in the vildagliptin group (6 vs. 11 events). Vildagliptin was non‐inferior (margin 0.6 mmol/l) to gliclazide in reducing fasting plasma glucose (1.31 vs. 1.52 mmol/l, P = 0.257). The overall incidence of any adverse events was similar in both groups (∼ 61%), but the number of serious adverse events was higher in the gliclazide group (8.7 vs. 6.7%). The number of patients who discontinued as a result of an unsatisfactory effect was higher in the vildagliptin group ( n = 22 vs. 13, respectively) compared with gliclazide, but vildagliptin did not induce weight gain. Conclusion In patients with Type 2 diabetes inadequately controlled with metformin, addition of vildagliptin provided similar HbA 1c ‐lowering efficacy compared with gliclazide after 52 weeks of treatment. Although both treatments were well tolerated, vildagliptin‐treated patients had fewer hypoglycaemic events and did not gain weight.