A new insulin formulation, AT278, absorbs into the bloodstream so quickly that it could let a computer—not the patient—decide every dose. Current artificial pancreas systems are only “hybrid closed loops”: they automatically adjust background insulin, but when blood sugar spikes after a meal, the patient must still manually trigger a bolus. That is because today’s fastest insulins, such as Novorapid, are too sluggish to keep glucose in check without human intervention. AT278, developed using Arecor’s formulation technology, showed in a Phase I trial that it enters and leaves the bloodstream faster than Novorapid. The upcoming Phase Ib trial will measure exactly how its time-action profile compares with Novorapid and Humulin R U500 in people with Type II diabetes. If AT278 proves fast enough, it would enable a fully closed loop system—one that continuously measures glucose, calculates the needed insulin, and delivers it automatically, including at mealtimes. For patients with Type I or Type II diabetes, that would mean no manual bolusing, fewer dangerous highs and lows, and better long-term health. For health systems, it could sharply reduce the costs of managing diabetes complications.
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AT278, a novel formulation of insulin with an ultra-rapid glucose lowering action, can transform diabetes care by enabling the development of a fully closed loop artificial pancreas (AP) system. The AT278 formulation was developed using Arecor's proprietary formulation technology and is based on a unique mixture of two ingredients. The first results in significant acceleration of insulin absorption from the injection site and the second ensures excellent stability of insulin in the pump. The ultra-rapid action of AT278 has already been demonstrated in a Phase I clinical trial where the onset and offset of exposure was superior to that Novorapid. The objective of the proposed Phase Ib trial is to compare the pharmacokinetic and pharmacodynamic time action profile of AT278 with Novorapid and Humulin R U500 when administered to patients with Type II diabetes. This is a critical step forward in understanding ultra-rapid-acting insulins and the translation of these products to automated insulin delivery systems. It has been shown that TIR is significantly improved when patients are using an automated insulin delivery system (AP), where BG is continuously measured, an algorithm calculates insulin requirements based on real-time BG which is then automatically delivered by a pump. Current best-in-class insulins are not fast enough acting to control BG within an AP system around meal-times (when BG rises rapidly) and the patient must manually intervene (hybrid closed loop, HCL). The challenge is to develop an ultra-rapid acting insulin that enables a fully closed loop AP system. This will be transformative for T1D and T2D patients, improving quality of life and health outcomes. In addition, a true AP system will ultimately greatly reduce the wider burden on health care systems globally.
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