Method of treating hypoglycemia events in diabetes treatment

Patent metadata

Field	Value
Publication number	US-11980656-B2
Application number	US-202117444381-A
Country	US
Kind code	B2
Filing date	Aug 3, 2021
Priority date	Aug 11, 2008
Publication date	May 14, 2024
Grant date	May 14, 2024

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.

First claim

What is claimed is:

1. A method of treating diabetes comprising:
a. selecting a patient being treated for diabetes type 1 with an insulin-pump;
b. replacing the insulin pump with an injectable therapy comprising a long-acting insulin administered upon waking; and
c. administering an inhalable insulin composition comprising a therapeutically effective dose of a pharmaceutical composition comprising insulin and fumaryl diketopiperazine to the patient at mealtime.

2. The method of claim 1 , wherein the pharmaceutical composition is administered using a dry powder inhaler.

3. The method of claim 2 , wherein the dry powder inhaler is for oral inhalation.

4. The method of claim 1 , wherein the long-acting basal insulin is insulin glargine, insulin aspart or insulin degludec.

5. The method of claim 4 , wherein the long-acting basal insulin is administered in the morning prior to a meal.

6. The method of claim 1 , wherein the inhalable insulin composition is provided in a single unit dose cartridge comprising 4 units, 8 units, or 12 units of insulin per dose.

Assignees

• Mannkind Corp

Inventors

• Grant Marshall
• Bruce Simon R
• Baughman Robert A

Classifications

• A61K38/28 Primary

  Insulins · CPC title

• A61K9/0021

  Intradermal administration, e.g. through microneedle arrays or needleless injectors · CPC title

• A61K9/0075

  for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles · CPC title

• A61K47/545

  Heterocyclic compounds (A61K47/558 takes precedence) · CPC title