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Divergent hypoglycemic effects of hepatic-directed prandial insulin: A six-month phase 2b study in type 1 diabetes

Diabetes Care Oct 03, 2019

Klonoff D, et al. - Because hepatic-directed vesicle insulin (HDV) utilizes a hepatocyte-targeting moiety passively attaching free insulin to improve the hepatic biodistribution of subcutaneous insulin, researchers assessed HDV-insulin lispro (HDV-L) compared with insulin lispro (LIS) in T1D. Of the 176 randomized candidates, the difference in change from baseline A1C was 0.09%, confirming noninferiority (prespecified margin ≤ 0.4%). Overall, no statistically significant differences were found between treatments for hypoglycemia or insulin dosing. Baseline A1C, however, modified the effect of treatment group on clinically apparent hypoglycemia, which was designated as severe by treatment-blind investigators. Thus, there was less hypoglycemia and reduced dosing of insulin at higher baseline A1C with comparable A1C results during HDV-L vs LIS, whereas the higher risk of hypoglycemia was noted with reduced baseline A1C despite comparable A1C results and insulin doses. With divergent clinical results in hypoglycemia based on baseline A1C, hepatic biodistribution of HDV-L appears to potentiate insulin impact in T1D. There were no identified safety signals.
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