Use of ultrarapid acting insulin
Inventors
Boss, Anders Hasager • Petrucci, Richard • Howard, Campbell • Mann, Alfred
Assignees
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Publication Number
US-12303554-B2
Publication Date
2025-05-20
Expiration Date
Abstract
Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Core Innovation
The document describes improved treatment of diabetes mellitus and hyperglycemia by administering a prandial ultrarapid-acting insulin formulated as an inhaled dry powder. In particular, the prandial insulin is an inhaled formulation comprising recombinant human insulin and a diketopiperazine, including insulin-FDKP (fumaryl diketopiperazine) and diketopiperazine microparticles, configured to mimic meal early-phase insulin kinetics.
The problem addressed in the background is inadequate control of post-prandial blood glucose and glucose excursions in diabetes patients when using prandial injected insulin, together with associated clinical drawbacks including risk of hypoglycemia and weight gain. The disclosed approach is designed to reduce post-meal glucose excursions by enabling faster insulin kinetics that more quickly suppress endogenous glucose production and improve glucose elimination.
The document further describes replacing prandial injected insulin with the inhaled insulin/diketopiperazine formulation, while using meal-tied post-prandial dosing based on blood glucose measurements. It also describes use as monotherapy or as a substitution for or addition to oral drugs such as metformin, insulin secretagogues, and insulin sensitizers such as TZDs, and combination with basal insulin, including insulin glargine, and insulin pump infusion scenarios.
Claims Coverage
The partial content provides one independent claim directed to reducing the risk of weight gain by replacing prandial injected insulin with an inhaled insulin/diketopiperazine formulation and using a post-prandial supplemental dose when blood glucose exceeds a threshold at a defined time after a meal.
Replacing prandial injected insulin with inhaled insulin and diketopiperazine
A method of reducing the risk of weight gain in a diabetes patient by replacing prandial injected insulin with an inhaled formulation comprising recombinant human insulin and a diketopiperazine.
Post-prandial supplemental dose when glucose exceeds threshold at 60 to 120 minutes
Further administering a post-prandial dose of the inhaled formulation if blood glucose levels exceed 140 mg/dL at 60 to 120 minutes after the meal.
Across the identified independent claim, the core inventive coverage is the replacement of prandial injected insulin with an inhaled formulation comprising recombinant human insulin and a diketopiperazine, together with a meal-timed post-prandial supplemental dose triggered by a specified blood glucose threshold at 60 to 120 minutes after the meal.
Stated Advantages
Reduced risk of weight gain.
Faster peak insulin and quicker suppression of hepatic glucose output.
Reduced post-prandial glucose excursions.
Reduced hypoglycemia risk.
Weight neutrality/weight loss.
Documented Applications
Treatment of diabetes mellitus, including type 1 and type 2, and hyperglycemia using prandial ultrarapid-acting insulin delivered as an inhaled dry powder formulation comprising recombinant human insulin and a diketopiperazine.
Use as monotherapy or substitution for or addition to oral drugs including metformin, insulin secretagogues, and insulin sensitizers such as TZDs.
Combination use with basal insulin, including insulin glargine, and scenarios involving insulin pump infusion.
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