IP Library Granted Patent US 11,931,404
Granted Patent B2
US 11,931,404 · App. 17/240,802 · Granted Mar 19, 2024

Use of ultrarapid acting insulin

Inventors: Anders Hasager Boss (Princeton, NJ); Richard Petrucci (New Canaan, CT)
Assignee: MannKind Corporation
A61K38/28A61K9/007A61K9/0075A61K31/155A61K9/0019
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Quick Facts
Patent No.
US 11,931,404
App. No.
17/240,802
Granted
Mar 19, 2024
Kind
B2
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.

Claims (20)

1. A method of treating diabetes comprising treating a subject who is monitored for pre-meal blood glucose levels for 10 days and regularly has a pre-meal blood glucose level greater than 100 mg/dL comprising:

administering by inhalation an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning the meal; wherein the pre-meal blood glucose of the subject for a next meal is regularly greater than 140 mg/dL.

2. The method of claim 1 , wherein said initial dose comprises up to 12 units of the ultrarapid acting insulin formulation.

3. The method of claim 2 , wherein said initial dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation.

4. The method of claim 1 , wherein said second dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation.

5. The method of claim 1 , wherein said initial dose is taken at mealtime.

6. The method of claim 1 , wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal is greater than 140 mg/dL.

7. The method of claim 1 , wherein said second dose is taken 60-150 minutes after beginning a meal.

8. The method of claim 7 , wherein said second dose is taken 90-150 minutes after beginning a meal.

9. The method of claim 1 , wherein said second dose is between 25% to 100% of the initial dose.

10. The method of claim 1 , wherein said ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-aminobutyl)-, 3,6-di(maleyl-4-aminobutyl)-, 3,6-di(glutaryl-4-aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-aminobutyl)-, or 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

11. The method of claim 10 , wherein said ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

12. The method of claim 11 , wherein said ultrarapid acting insulin comprises human insulin.

13. The method of claim 12 , wherein administration is by inhalation.

14. The method of claim 13 , wherein administration by inhalation comprises use of a breath-powered inhaler.

15. The method of claim 14 , wherein said diabetes comprises type 1 diabetes.

16. The method of claim 14 , wherein said diabetes comprises type 2 diabetes.

17. The method of claim 1 , wherein said pre-meal blood glucose is determined with continuous blood glucose monitoring.

18. The method of claim 1 , wherein said subject is also being treated with a GLP-1 agonist.

19. The method of claim 1 , wherein said subject is overweight.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072444/0525 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2021
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD
To: MANNKIND CORPORATION
Reel/Frame 056044/0423 →