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U‐100, pH‐Neutral formulation of VIAject ® : faster onset of action than insulin lispro in patients with type 1 diabetes
Author(s) -
Heinemann L.,
Nosek L.,
Flacke F.,
Albus K.,
Krasner A.,
Pichotta P.,
Heise T.,
Steiner S.
Publication year - 2012
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.1463-1326.2011.01516.x
Subject(s) - insulin lispro , insulin , pharmacodynamics , bioequivalence , crossover study , medicine , onset of action , pharmacokinetics , confidence interval , type 2 diabetes , diabetes mellitus , endocrinology , chemistry , human insulin , placebo , alternative medicine , pathology
Aims: VIAject ® is a formulation of human insulin with a very fast onset of action. Previous studies used VIAject in a concentration of 25 U/ml and a pH of 4 [VIAject 25 (VJ25)]. Objective of this double blind, three‐way crossover study was to compare the pharmacodynamic/pharmacokinetic properties of a novel formulation of VIAject with a concentration of 100 U/ml and a neutral pH [VIAject 7 (VJ7)] with VJ25 and insulin lispro (LIS). Methods: Forty‐three patients with type 1 diabetes [aged 43 (21–65) years, BMI 24.1 (20–28) kg/m 2 and HbA1c 7.5 (5.7–9.5) %] participated in this study. They received subcutaneous injections of 12 U of each insulin formulation under euglycaemic glucose clamp conditions. Results: VJ7 was bioequivalent to VJ25 [90% confidence interval (CI) of the ratios for total insulin AUCs and maximum insulin concentration ( C INS max ) was within 0.80–1.25]. VJ7 showed a faster absorption compared to LIS [time to C INS max 23 vs. 60 min; difference (CI) −30 (−35 to −23)] and faster onset of action [time to early half‐maximal glucose infusion rate (GIR) 25 vs. 44 min; −18 (−26 to −10)], and a higher AUC of glucose infusion rate (AUC GIR ) in the first 60 min after injection [176 vs. 107 mg/kg; ratio 1.65 (1.27 to 2.14)], contributing to a slightly higher value for AUC GIR 0–480 [1263 vs. 1095 mg/kg; 1.15 (1.06 to 1.26)]. Maximum GIR was similar between VJ7 and LIS [6.1 vs.6.6 mg/kg/min; ratio 0.93 (0.86 to 1.01)], whereas the duration of action ( t GIR50%–late ) was longer with VJ7 [274 vs. 228 min; 50 (25 to 73)]. Conclusions: This formulation of VIAject is bioequivalent to the previously used formulation and has a faster absorption/onset of action than LIS.