IP Library Granted Patent US 12,303,554
Granted Patent B2
US 12,303,554 · App. 18/077,742 · Granted May 20, 2025

Use of ultrarapid acting insulin

Inventors: Anders Hasager Boss (Princeton, NJ); Richard Petrucci (New Canaan, CT); Campbell Howard (Yardley, PA); Alfred Mann (Valencia, CA)
Assignee: MannKind Corporation
A61K38/28A61K9/0021A61K9/0075A61K47/545
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Quick Facts
Patent No.
US 12,303,554
App. No.
18/077,742
Granted
May 20, 2025
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 (19)

1. A method of reducing the risk of weight gain in a diabetes patient currently using a prandial injected insulin, said method comprising replacing said prandial injected insulin with an inhaled formulation comprising a recombinant human insulin and a diketopiperazine, further comprising administering a post-prandial dose of the inhaled formulation if blood glucose levels exceeds 140 mg/dL at 60 to 120 minutes after the meal.

2. The method of claim 1 , wherein the inhaled formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

3. The method of claim 2 , wherein the inhaled formulation comprises an insulin dosage of up to 32 units.

4. The method of claim 2 , wherein the inhaled formulation is a dry powder.

5. The method of claim 4 , wherein the inhaled formulation is administered using a dry powder inhaler.

6. The method of claim 5 , further comprising administration of a long-acting insulin analog within 6 hours of waking.

7. The method of claim 6 , wherein the administration of the long acting insulin analog is within 3 hours of waking.

8. The method of claim 7 , wherein the long acting insulin analog is insulin detemir or insulin glargine.

9. The method of claim 8 , wherein the long acting insulin analog is insulin detemir.

10. The method of claim 8 , wherein the long acting insulin analog is insulin glargine.

11. The method of claim 2 , wherein the inhaled formulation comprises a 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine salt.

12. The method of claim 1 , wherein the inhaled formulation comprising a recombinant human insulin and a diketopiperazine is an ultrarapid acting insulin.

13. The method of claim 12 , wherein the ultrarapid acting insulin is administered with at least two meals each day.

14. The method of claim 1 , wherein said patient has diabetes mellitus.

15. The method of claim 14 , wherein the diabetes mellitus comprises diabetes type 2.

16. The method of claim 15 , further comprising determination of the patient's dosage by identifying the meal resulting in the highest 2-hour post-prandial blood glucose levels using 7 point SMBG (serum measured blood glucose), and titrating up the dosage for that meal.

17. The method of claim 16 , wherein said meal comprises one of breakfast, lunch, dinner, or regularly occurring snack.

18. The method of claim 17 , wherein said titrating comprises iteratively increasing the dosage.

19. The method of claim 18 , wherein said titrating occurs within a titration period of not more than a week.

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 Dec 8, 2022
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD; HOWARD, CAMPBELL; MANN, ALFRED
To: MANNKIND CORPORATION
Reel/Frame 062032/0971 →