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Improved glycaemic control with dipeptidyl peptidase‐4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose response
Author(s) -
Ristic S.,
Byiers S.,
Foley J.,
Holmes D.
Publication year - 2005
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.1463-1326.2005.00539.x
Subject(s) - vildagliptin , postprandial , placebo , medicine , type 2 diabetes , dose , dipeptidyl peptidase 4 , endocrinology , diabetes mellitus , adverse effect , hypoglycemia , pharmacology , alternative medicine , pathology
Objective: A novel treatment option for diabetic patients is the enhancement of incretin hormone activity by inhibition of the enzyme dipeptidyl peptidase‐4 (DPP‐4). This study was designed to establish a dose of the DPP‐4‐inhibitor vildagliptin (LAF237) that was effective in reducing HbA1c levels and was safe and well tolerated in patients with type 2 diabetes. Patients and Methods: The study of 279 patients with type 2 diabetes consisted of a 4‐week run‐in phase where patients received placebo and a 12‐week active treatment phase where they received one of the following dosages of vildagliptin: 25 mg twice daily, 25, 50 or 100 mg once daily (qd), or placebo. Results: There was a statistically significant reduction in HbA1c levels in the vildagliptin 50 mg qd (p = 0.003) and 100 mg qd groups (p = 0.004) compared with the placebo group. The mean 4‐h postprandial glucose level was significantly reduced from placebo in the vildagliptin 50 mg qd group (p = 0.012) and mean 4‐h postprandial insulin was significantly increased from baseline vs. placebo in the vildagliptin 100 mg qd group (p = 0.022). The assessment of β‐cell function (HOMA‐B) was significantly increased in the vildagliptin 100 mg qd treatment group (p = 0.007). The incidence of adverse events was similar in all treatment groups including placebo. Conclusions: Vildagliptin, at 50 and 100 mg qd, was effective in reducing HbA1c levels compared with placebo in patients with type 2 diabetes. Vildagliptin at dosages up to 100 mg qd appeared safe and well tolerated.