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Comparison of vildagliptin and thiazolidinedione as add‐on therapy in patients inadequately controlled with metformin: results of the GALIANT trial – a primary care, type 2 diabetes study
Author(s) -
Blonde L.,
DagogoJack S.,
Banerji M. A.,
Pratley R. E.,
Marcellari A.,
Braceras R.,
Purkayastha D.,
Baron M.
Publication year - 2009
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2009.01080.x
Subject(s) - vildagliptin , medicine , metformin , tolerability , type 2 diabetes , clinical endpoint , diabetes mellitus , body mass index , adverse effect , randomized controlled trial , endocrinology
Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12‐week, open‐label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators’ discretion, n = 825) add‐on therapy in patients inadequately controlled [haemoglobin A 1C (HbA 1c ): 7–10%] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non‐inferiority of vildagliptin to TZDs for the difference in change in HbA 1c from baseline [established if the upper limit of the two‐sided 95% confidence intervals (CI) did not exceed 0.4%]. Results: Mean (± s.e.) change in HbA 1c from baseline to study endpoint was –0.68 ± 0.02% in the vildagliptin group and −0.57 ± 0.03% in the TZD group. The difference between groups was −0.11% (95% CI: −0.17% and −0.04%), establishing the non‐inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non‐inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: −0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short‐term study suggests that vildagliptin is as effective as TZDs after 3‐month treatment as an add‐on to metformin in a primary care population that included diverse patient subgroups.