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Vildagliptin add‐on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2‐year study
Author(s) -
Matthews D. R.,
Dejager S.,
Ahren B.,
Fonseca V.,
Ferrannini E.,
Couturier A.,
Foley J. E.,
Zinman B.
Publication year - 2010
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.1463-1326.2010.01233.x
Subject(s) - vildagliptin , glimepiride , medicine , metformin , diabetes mellitus , type 2 diabetes , gastroenterology , endocrinology
Aim: To show that vildagliptin added to metformin is non‐inferior to glimepiride in reducing HbA1c levels from baseline over 2 years. Methods: A randomized, double‐blind, active‐comparator study of patients with type 2 diabetes mellitus inadequately controlled (HbA1c 6.5–8.5%) by metformin monotherapy. Patients received vildagliptin (50 mg twice daily) or glimepiride (up to 6 mg/day) added to metformin. Results: In all, 3118 patients were randomized (vildagliptin, n = 1562; glimepiride, n = 1556). From similar baseline values (7.3%), after 2 years adjusted mean (s.e.) change in HbA1c was comparable between vildagliptin and glimepiride treatment: −0.1% (0.0%) and −0.1% (0.0%), respectively. The primary objective of non‐inferiority was met. A similar proportion of patients reached HbA1c <7% (36.9 and 38.3%, respectively), but with vildagliptin more patients reached this target without hypoglycaemia (36.0% vs. 28.8%; p = 0.004). The initial response (IR) was sustained for a mean (s.d.) of 309 (244) days with vildagliptin versus 270 (223) days for glimepiride (p < 0.001) (IR = nadir HbA1c where change from baseline ≥0.5% or HbA1c ≤6.5% within the first six months of treatment. After IR was detected, sustained response = time between nadir and an increase of >0.3% above IR). Independent of disease duration, age was a predictor of effect sustainability. Fewer patients experienced hypoglycaemia with vildagliptin (2.3% vs. 18.2% with glimepiride) with a 14‐fold difference in the number of hypoglycaemic events (59 vs. 838). Vildagliptin had a beneficial effect on body weight [mean (s.e.) change from baseline −0.3 (0.1) kg; between‐group difference −1.5 kg; p < 0.001]. Overall, both treatments were well tolerated and displayed similar safety profiles. Conclusions: Vildagliptin add‐on has similar efficacy to glimepiride after 2 years' treatment, with markedly reduced hypoglycaemia risk and no weight gain.