A novel insulin formulation with a more rapid onset of action

Abstract

Aims/hypothesisThis study evaluates the pharmacodynamic and pharmacokinetic properties of the novel ultra-fast insulin product VIAject, a formulation of human soluble insulin and generally recognised as safe ingredients designed to increase the rate of absorption.MethodsWe performed five euglycaemic glucose clamps (Biostator; target blood glucose 5 mmol/l) in ten healthy volunteers. Using a crossover design with a fixed treatment order, 12 IU human soluble insulin, 12 U insulin lispro and 12 IU ultra-fast insulin were injected s.c. in the abdominal region on three study days. On the other two study days, 6 and 3 IU ultra-fast insulin were injected.ResultsSubcutaneous injection of 12 IU ultra-fast insulin resulted in a time–action profile characterised by an even more rapid onset of action and maximal metabolic activity than insulin lispro: time to early half-maximal activity was 33 ± 17 min (mean ± SD) vs insulin lispro 51 ± 13 min vs human soluble insulin 66 ± 15 min (p < 0.05 ultra-fast insulin<insulin lispro<human soluble insulin); time to maximal activity was 136 ± 56 min vs insulin lispro 152 ± 30 min vs human soluble insulin 193 ± 57 min (p < 0.05 ultra-fast insulin and insulin lispro<human soluble insulin). The metabolic activity in the first 2 h after injection was higher with ultra-fast insulin and insulin lispro than with human soluble insulin (AUC glucose infusion rate [GIR] 0–120 min: 915 ± 301 and 781 ± 174 vs 580 ± 164 mg/kg; p < 0.05). A clear dose–response relationship was observed with the three doses of ultra-fast insulin: AUCGIR 0–120 min 12 IU 915 ± 301 vs 6 IU 718 ± 255 vs 3 IU 524 ± 262 mg/kg (p < 0.05). The pharmacokinetic data confirmed the pharmacodynamic results.Conclusions/interpretationThis study shows that the onset of action of VIAject is faster than that of human soluble insulin and insulin lispro.

Ultrafast-Acting Insulins: State of the Art

“…50,51 In a proof-of-concept clamp study with 10 healthy subjects, this formulation was absorbed twice as fast as RHI and slightly faster than a RAIA; maximal glucose-lowering action was also reached faster. In a meal study, use of this insulin resulted in lower PPG than RHI or RAIA.…”

The role of hormonal treatment in type 2 diabetes mellitus

“…The time to half maximal activity of Linjeta was found to be 33 minutes, 18 minutes faster than insulin lispro and 33 minutes faster than regular human insulin. 84 Linjeta has been shown to decrease oxidative stress and postprandial hyperglycemia and hypoglycemia and improve endothelial functions in T2DM. 85 …”

Recombinant Insulin in Type 2 Diabetes Treatment: Where Are We Now?

“…Among these new formulations, there are faster insulins, such as VIAject (Biodel Inc. Danbury, CT), with a more rapid onset of action, potentially even faster than the currently available RAAs, and others, which are aimed to ameliorate current LAAs' properties, such as BI-OD-Adjustable Basal (Biodel Inc. Danbury, CT), and BI-OD-Smart Basal, including glargine in their molecules [37][38][39].…”