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- Title
Efficacy and Tolerability of Vildagliptin in Drug-Naïve Patients with Type 2 Diabetes (T2DM) and Mild Hyperglycemia.
- Authors
Scherbaum, W. A.; Schweizer, A.; Mari, A.; Nilsson, P. M.; Lalanne, G.; Jauffret, S.; Foley, J. E.
- Abstract
Vildagliptin is a potent and selective DPP-4 inhibitor that improves glycemic control in patients with T2DM by increasing both α- and β-cell responsiveness to glucose. In earlier studies enrolling patients with T2DM and baseline A1C of 7.5 to 11%, vildagliptin 100 mg daily was very well-tolerated and decreased mean A1C by 1% or more. However, despite current trends toward earlier and more aggressive intervention, patients with T2DM and only mild hyperglycemia are not well-studied. This 52-week, randomized study examined efficacy and tolerability of vildagliptin 50 mg qd (n = 156) vs placebo (n = 150) in patients with T2DM and mild hyperglycemia (A1C of 6.2 to 7.5%). All patients received lifestyle counseling at every visit. Standard meal tests were performed at baseline and endpoint and insulin secretion relative to glucose (ISR AUC[sub 0-2h]/glucose AUC[sub 0.2h]) was calculated as an index of β-cell function. At baseline mean age = 63.1 y (47% aged ≥65 y), BMI = 30.2 kg/m², FPG = 7.1 mM and A1C = 6.7%. Relative to placebo, vildagliptin significantly increased β-cell function (5.0 ± 1.2 pmol/min/m²/mM, P < 0.001), and decreased 2-h postprandial glucose (-0.9 ± 0.4 mM, P = 0.012) and FPG (-0.4 ± 0.2 mM, P = 0.032). In patients receiving vildagliptin, the placebo-adjusted change in A1C from baseline to endpoint was -0.3 ± 0.1% (P < 0.001). Endpoint A1C ≤6.5% was achieved by 45.1% and 21.6% of patients in the vildagliptin and placebo groups, respectively. Body weight decreased both in patients receiving placebo (-0.2 ± 0.3 kg) and vildagliptin (-0.5 ± 0.3 kg). One or more AE was reported by 73.1% of vildagliptin-treated patients and by 72.7% of those receiving placebo. One hypoglycemic event occurred in 1 patient receiving placebo and in no patient receiving vildagliptin. Conclusion: in drug-naive patients with T2DM and mild hyperglycemia, vildagliptin 50 mg qd is well-tolerated and decreases A1C primarily by improving β-cell function and decreasing postprandial glucose.
- Publication
Diabetes, 2007, Vol 56, pA134
- ISSN
0012-1797
- Publication type
Academic Journal