Method of treating hypoglycemia events in diabetes treatment
Inventors
Grant, Marshall • Bruce, Simon R. • Baughman, Robert A.
Assignees
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Publication Number
US-11980656-B2
Publication Date
2024-05-14
Expiration Date
Abstract
An ultra-rapid acting insulin composition and method for treating hyperglycemia in patients with diabetes are disclose. The composition is an inhalable dry powder composition comprising fumaryl diketopiperazine and insulin for pulmonary delivery, which significantly reduces the rates of hypoglycemic events in patients in patients on mealtime insulin therapy.
Core Innovation
The disclosed subject matter relates to treating diabetes with an inhalable ultra-fast acting insulin composition in dry powder form. The inhalable composition includes insulin and fumaryl diketopiperazine, also described as a diketopiperazine carrier, delivered for pulmonary delivery and used for mealtime insulin therapy by administering a therapeutically effective dose at mealtime.
The disclosed rationale targets physiologic meal early-phase insulin kinetics by using an ultra-rapid acting insulin profile that achieves a rapid peak followed by a return toward baseline. The document links this kinetic goal to reducing hypoglycemia during and/or after mealtime insulin therapy, and describes patient-selection concepts including selecting a patient being treated for type 1 diabetes with an insulin-pump.
A treatment regimen is described in which the insulin pump is replaced with an injectable long-acting insulin administered upon waking, while mealtime insulin is provided by inhalation of the insulin-fumaryl diketopiperazine composition. Delivery-system concepts are described, including a dry powder inhaler and cartridge or unit-dose concepts, with respirable fraction considerations and diketopiperazine microparticles for deep-lung deposition and rapid dissolution and release.
Claims Coverage
The partial content identifies one independent claim directed to a diabetes-treatment method combining a pump-to-injection switch for long-acting basal insulin with mealtime administration of an inhalable insulin composition containing insulin and fumaryl diketopiperazine. Dependent claims refine this by specifying the inhalation device and route, narrowing the injectable basal insulin types and timing, and specifying a single-unit-dose cartridge format.
Selecting a type 1 diabetes patient on an insulin-pump
Selecting a patient being treated for diabetes type 1 with an insulin-pump.
Replacing the insulin pump with waking long-acting injectable insulin
Replacing the insulin pump with an injectable therapy comprising a long-acting insulin administered upon waking.
Administering inhalable insulin-fdkp at mealtime
Administering an inhalable insulin composition at mealtime, comprising a therapeutically effective dose of a pharmaceutical composition comprising insulin and fumaryl diketopiperazine.
Using a dry powder inhaler for the inhalable composition
Administering the inhalable insulin composition using a dry powder inhaler.
Delivering the inhalable composition as oral inhalation
Using the dry powder inhaler for oral inhalation.
Using specified long-acting basal insulin types
Using as the long-acting basal insulin one of insulin glargine, insulin aspart, or insulin degludec.
Morning timing of the waking long-acting basal insulin
Administering the long-acting basal insulin in the morning before a meal.
Single-unit-dose cartridge dosing format
Providing the inhalable insulin composition as a single-unit-dose cartridge containing 4, 8, or 12 units of insulin per dose.
Across the independent method and refinements, the core claimed approach is a regimen for type 1 diabetes that selects insulin-pump patients, replaces the pump with waking long-acting injectable insulin, and administers an inhalable insulin composition containing insulin and fumaryl diketopiperazine at mealtime. Dependent claim refinements specify dry powder inhaler and oral inhalation delivery, constrain basal insulin to named insulin types and timing, and define a single-unit-dose cartridge format with specified unit amounts per dose.
Stated Advantages
Reduces hypoglycemic incidence and severe hypoglycemia rates while maintaining noninferior glycemic control (HbA1c).
Documented Applications
Treatment of diabetes mellitus, including type 1 diabetes, using mealtime insulin therapy with an inhalable insulin-fumaryl diketopiperazine dry powder composition and an injectable long-acting insulin administered upon waking.
Patient selection in a type 1 diabetes setting where the patient is treated with an insulin-pump and the pump is replaced with waking long-acting injectable insulin while administering inhalable insulin at mealtime.
Comparison in a Type 1 trial (AFFINITY 1) of inhalable TI versus injected insulin aspart, including post-hoc analysis of hypoglycemia incidence, events, and severe hypoglycemia while maintaining noninferior HbA1c.
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