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
(2010) In Diabetes, Obesity and Metabolism 12(9). p.780-789- Abstract
- 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... (More)
- 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/1656057
- author
- Matthews, D. R. ; Dejager, S. ; Ahrén, Bo LU ; Fonseca, V. ; Ferrannini, E. ; Couturier, A. ; Foley, J. E. and Zinman, B.
- organization
- publishing date
- 2010
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- vildagliptin, mellitus, type 2 diabetes, hypoglycaemia, glimepiride, DPP-4 inhibitor, elderly
- in
- Diabetes, Obesity and Metabolism
- volume
- 12
- issue
- 9
- pages
- 780 - 789
- publisher
- Wiley-Blackwell
- external identifiers
-
- wos:000280254000007
- scopus:77955048324
- pmid:20649630
- ISSN
- 1462-8902
- DOI
- 10.1111/j.1463-1326.2010.01233.x
- language
- English
- LU publication?
- yes
- id
- 523749b6-3b69-4ddb-9721-9830add883f7 (old id 1656057)
- date added to LUP
- 2016-04-01 10:45:33
- date last changed
- 2024-10-07 12:49:37
@article{523749b6-3b69-4ddb-9721-9830add883f7,
abstract = {{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.}},
author = {{Matthews, D. R. and Dejager, S. and Ahrén, Bo and Fonseca, V. and Ferrannini, E. and Couturier, A. and Foley, J. E. and Zinman, B.}},
issn = {{1462-8902}},
keywords = {{vildagliptin; mellitus; type 2 diabetes; hypoglycaemia; glimepiride; DPP-4 inhibitor; elderly}},
language = {{eng}},
number = {{9}},
pages = {{780--789}},
publisher = {{Wiley-Blackwell}},
series = {{Diabetes, Obesity and Metabolism}},
title = {{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}},
url = {{http://dx.doi.org/10.1111/j.1463-1326.2010.01233.x}},
doi = {{10.1111/j.1463-1326.2010.01233.x}},
volume = {{12}},
year = {{2010}},
}