PUMA
Istituto di Ingegneria Biomedica     
Mari A., Scherbaum W. A., Nilsson P. M., Lalanne G., Schweizer A., Dunning B. E., Jauffret S., Foley J. E. Characterization of the Influence of Vildagliptin on Model-Assessed b-Cell Function in Patients with Type 2 Diabetes and Mild Hyperglycemia. In: Journal of Clinical Endocrinology and Metabolism, vol. 93 (1) pp. 103 - 9. The Endocrine Society, 2008.
 
 
Abstract
(English)
Objective: This study was conducted to characterize the effects of vildagliptin on beta-cell function in patients with type 2 diabetes and mild hyperglycemia. Design: A 52-wk double-blind, randomized, parallel-group study comparing vildagliptin (50 mg qd) and placebo was conducted in 306 patients with mild hyperglycemia (A1C = 6.2-7.5%). Plasma glucose and C-peptide levels were measured during standard meal tests performed at baseline, wk 24 and 52, and after 4-wk washout. Insulin secretory rate (ISR) was calculated by C-peptide deconvolution and beta-cell function was quantified with a mathematical model that describes ISR as a function of absolute glucose levels (insulin secretory tone and glucose sensitivity), the glucose rate of change (rate sensitivity), and a potentiation factor. Results: Vildagliptin significantly increased fasting insulin secretory tone (between-group difference in adjusted mean change from baseline to wk 52 [Delta]= +34.1 +/- 9.5 pmol*min(-1) *m(-2), P<0.001) glucose sensitivity (Delta= +20.7 +/- 5.2 pmol*min(-1) *m(-2) *mM(-1), P < 0.001) and rate sensitivity (Delta= +163.6 +/- 67.0 pmol*m(-2) *mM(-1), P = 0.015) but total insulin secretion (ISR AUC0-2h) and the potentiation factor excursion during meals were unchanged. These improvements in beta-cell function were accompanied by a decrease in the glucose AUC0-2h (Delta = -1.7 +/- 0.5 mM*h, P = 0.002) and in A1C (Delta = -0.3 +/- 0.1%, P < 0.001). None of the effects of vildagliptin remained following 4-wk washout from study medication. Conclusions: Consistent with previous findings from shorter-term studies in patients with more severe hyperglycemia, in patients with mild hyperglycemia, improved beta-cell function is maintained throughout 52-wk treatment with vildagliptin and underlies a sustained improvement in glycemic control. However, no effects remain after washout.
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17925336
DOI: 10.1210/jc.2007-1639
Subject Vildagliptin
Model-Assessed b-Cell Function
Type 2 Diabetes
Mild Hyperglycemia


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