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Andrea Mari, Werner A. Scherbaum, Peter M. Nilsson, Gerard Lalanne, Anja Schweizer, Beth E. Dunning, Sophie Jauffret, James E. Foley, Characterization of the Influence of Vildagliptin on Model-Assessed β-Cell Function in Patients with Type 2 Diabetes and Mild Hyperglycemia, The Journal of Clinical Endocrinology & Metabolism, Volume 93, Issue 1, 1 January 2008, Pages 103–109, https://doi.org/10.1210/jc.2007-1639
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Abstract
Objective: This study was conducted to characterize the effects of vildagliptin on β-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 every day) and placebo was conducted in 306 patients with mild hyperglycemia (glycosylated hemoglobin of 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 β-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 (AMΔ) = +34.1 ± 9.5 pmol·min−1·m−2, P < 0.001] glucose sensitivity (AMΔ = +20.7 ± 5.2 pmol·min−1·m−2·mm−1, P < 0.001), and rate sensitivity (AMΔ = +163.6 ± 67.0 pmol·m−2·mm−1, P = 0.015), but total insulin secretion (ISR area under the curve at 0–2 h) and the potentiation factor excursion during meals were unchanged. These improvements in β-cell function were accompanied by a decrease in the glucose area under the curve at 0–2 h (AMΔ = −1.7 ± 0.5 mm/h, P = 0.002) and in glycosylated hemoglobin (AMΔ = −0.3 ± 0.1%, P < 0.001). None of the effects of vildagliptin remained after 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 β-cell function is maintained throughout 52-wk treatment with vildagliptin and underlies a sustained improvement in glycemic control. However, no effects remain after washout.
