Journal
DIABETES & METABOLISM JOURNAL
Volume 35, Issue 5, Pages 529-535Publisher
KOREAN DIABETES ASSOC
DOI: 10.4093/dmj.2011.35.5.529
Keywords
Diabetes mellitus; type 2; Glimepiride; Metformin; Vildagliptin
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Funding
- Chungbuk National University
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Background: The present study investigated the efficacy and safety of vildagliptin-metformin treatment compared to those of glimepiride-metformin treatment for type 2 diabetes. Methods: In a randomized, open-label, comparative study, 106 patients with type 2 diabetes were enrolled. The primary endpoint was a reduction in HbA1c from baseline and secondary endpoints included fasting plasma glucose (FPG) or 2-hour postprandial glucose (2h-PPG) reduction from baseline, as well as HbA1c responder rate and HbA1c reduction according to baseline HbA1c category. Results: Comparable HbA1c reduction was observed with a mean +/- standard deviation change from baseline to the 32-week endpoint of -0.94 +/- 1.15% in the vildagliptin group and -1.00 +/- 1.32% in the glimepiride group. A similar reduction in 2h-PPG (vildagliptin group 3.53 +/- 4.11 mmol/L vs. the glimepiride group 3.72 +/- 4.17 mmol/L) was demonstrated, and the decrements in FPG (vildagliptin group 1.54 +/- 2.41 mmol/L vs. glimepiride group 2.16 +/- 2.51 mmol/L) were not different between groups. The proportion of patients who achieved an HbA1c less than 7% at week 32 was 50.1% in the vildagliptin group and 56.0% in the glimepiride group. An average body weight gain of 2.53 +/- 1.21 kg in the glimepiride group was observed in contrast with the 0.23 +/- 0.69 kg weight gain noted in the vildagliptin group. A 10-fold lower incidence of hypoglycemia was demonstrated in the vildagliptin group, in addition to an absence of severe hypoglycemia. Conclusion: Vildagliptin-metformin treatment provided blood glucose control efficacy comparable to that of glimepiride-metformin treatment and resulted in better adverse event profiles with lower risks of hypoglycemia and weight gain.
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