IP Library Patent Application 19187193
Patent Application
App. No. 19/187,193

USE OF ULTRARAPID ACTING INSULIN

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Patent No.
US None
App. No.
19/187,193
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 in a 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.

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 1 , wherein the inhaled formulation comprising a recombinant human insulin and a diketopiperazine is an ultrarapid acting insulin.

10 ) The method of claim 9 , wherein the ultrarapid acting insulin is administered with at least two meals each day.

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

12 ) The method of claim 11 , wherein the diabetes mellitus comprises diabetes type 2.

13 ) The method of claim 1 , 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.

14 ) The method of claim 12 , 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.

15 ) The method of claim 14 , wherein said meal comprises one of breakfast, lunch, dinner, or regularly occurring snack.

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

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

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

19 ) The method of claim 15 , wherein said titrating comprises iteratively increasing the dosage.

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

Assignments (1)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072445/0769 →