U-100, pH-Neutral formulation of VIAject®: faster onset of action than insulin lispro in patients with type 1 diabetes

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Abstract

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/m2 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 (CINS max) was within 0.80–1.25]. VJ7 showed a faster absorption compared to LIS [time to CINS 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 (AUCGIR) 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 AUCGIR 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 (tGIR50%–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.

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