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- Title
Robust improvements in fasting and prandial measures of β-cell function with vildagliptin in drug-naïve patients: analysis of pooled vildagliptin monotherapy database.
- Authors
Pratley, R. E.; Schweizer, A.; Rosenstock, J.; Foley, J. E.; Banerji, M. A.; Pi-Sunyer, F. X.; Mills, D.; Dejager, S.
- Abstract
Aim: To assess the effects of 24-week treatment with vildagliptin on measures of β-cell function in a broad spectrum of drug-naïve patients with type 2 diabetes (T2DM). Methods: Data from all double-blind, multicentre, randomized, placebo- or active-controlled trials conducted in drug-naïve patients with T2DM were pooled from all patients receiving monotherapy with vildagliptin (100 mg daily: 50 mg twice daily or 100 mg once daily, n = 1855) or placebo (n = 347). Fasting measures of β-cell function [homeostasis model assessment of β-cell function (HOMA-B) and proinsulin : insulin ratio] were assessed in the overall pooled monotherapy population. Standard meal tests were performed at baseline and week 24 in a subset of patients, and effects of vildagliptin (100 mg daily, n = 227) on dynamic (meal test–derived) measures of β-cell function [insulin secretion rate relative to glucose (ISR/G) and insulinogenic indices] were assessed relative to baseline and vs. placebo (n = 29). Results: In the overall population, vildagliptin significantly increased HOMA-B both relative to baseline [adjusted mean change (AMΔ) = 10.3 ± 1.5] and vs. placebo (between-treatment difference in AMΔ = 11.5 ± 4.5, p = 0.01) and significantly decreased the proinsulin : insulin ratio relative to baseline (AMΔ = −0.05 ± 0.01) and vs. placebo (between-treatment difference in AMΔ = −0.09 ± 0.02, p < 0.001). Relative to baseline, vildagliptin monotherapy significantly increased all meal test–derived parameters, and ISR/G (between-treatment difference in AMΔ = 9.8 ± 2.8 pmol/min/m2/mM, p < 0.001) and the insulinogenic index0–peak glucose (between-treatment difference in AMΔ = 0.24 ± 0.05 pmol/mmol, p = 0.045) were significantly increased vs. placebo. Conclusions: Vildagliptin monotherapy consistently produced robust improvements in both fasting and meal test–derived measures of β-cell function across a broad spectrum of drug-naïve patients with T2DM. All Phase III trials described (NCT 00099905, NCT 00099866, NCT 00099918, NCT 00101673, NCT 00101803 and NCT 00120536) are registered with ClinicalTrials.gov.
- Subjects
TYPE 2 diabetes; PLACEBOS; HOMEOSTASIS; CELL physiology; INSULIN therapy
- Publication
Diabetes, Obesity & Metabolism, 2008, Vol 10, Issue 10, p931
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/j.1463-1326.2007.00835.x