IP Library Granted Patent US 10,046,031
Granted Patent B2
US 10,046,031 · App. 15/421,743 · Granted Aug 14, 2018

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 10,046,031
App. No.
15/421,743
Granted
Aug 14, 2018
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 (16)

1. A method of controlling glycemia related to a daily meal for a patient with delayed or prolonged nutrient absorption comprising the steps of:

selecting a patient with delayed nutrient absorption;

administering to the patient with delayed nutrient absorption 50% to 75% of a predetermined dosage of an ultrarapid acting insulin formulation at mealtime for the daily meal; and

administering the remainder of the predetermined dosage 30 to 120 minutes after beginning the daily meal.

2. The method of claim 1 wherein the ultrarapid acting insulin formulation comprises a diketopiperazine.

3. The method of claim 2 wherein said diketopiperazine comprises at least one of 3,6-di(succinyl-4-aminobutyl)-diketopiperazine, 3,6-di(maleyl-4-aminobutyl)-diketopiperazine, 3,6-di(glutaryl-4-aminobutyl)-diketopiperazine, 3,6-di(malonyl-4-aminobutyl)-diketopiperazine, 3,6-di(oxalyl-4-aminobutyl)-diketopiperazine, and 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

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

5. The method of claim 1 wherein the nutrient absorption is delayed and is related to a disease state.

6. The method of claim 1 wherein the nutrient absorption is delayed and is related to a meal content high in fat or fiber.

7. The method of claim 1 wherein the nutrient absorption is prolonged and is related to a prolonged meal.

8. The method of claim 1 wherein the ultrarapid acting insulin is administered by inhalation into the lungs.

9. The method of claim 8 , wherein the ultrarapid acting insulin is administered with a unit dose inhaler.

10. The method of claim 9 , wherein said administration comprises a dose of between 7.5 IU to 120 IU.

11. The method of claim 10 , wherein said administration comprises a dose of between 15 IU to 90 IU.

12. The method of claim 11 , wherein said administration comprises a dose of greater than 24 IU.

13. The method of claim 1 wherein 50% to 75% of the predetermined dosage of the ultrarapid acting insulin formulation is administered 10 minutes before to 30 minutes after beginning the daily meal.

Assignments (5)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072444/0525 →
RELEASE OF SECURITY INTEREST Recorded Apr 5, 2024
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: MANNKIND CORPORATION; MANNKIND LLC
Reel/Frame 067024/0082 →
RELEASE OF SECURITY INTEREST Recorded Aug 13, 2019
From: DEERFIELD PRIVATE DESIGN FUND II, L.P.; DEERFIELD PRIVATE DESIGN INTERNATIONAL II, L.P.; HORIZON SANTE FLML SARL
To: MANNKIND CORPORATION
Reel/Frame 050044/0138 →
SECURITY INTEREST Recorded Aug 13, 2019
From: MANNKIND CORPORATION; MANNKIND LLC
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 050044/0181 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2017
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD; HOWARD, CAMPBELL; MANN, ALFRED
To: MANNKIND CORPORATION
Reel/Frame 043153/0724 →
Continuity (7)
Continuation 13357821 · Jan 25, 2012
Continuation 12539499 · Aug 11, 2009
Provisional Application 61087943 · Aug 11, 2008
Provisional Application 61097495 · Sep 16, 2008
Provisional Application 61097516 · Sep 16, 2008
Provisional Application 61138863 · Dec 18, 2008
Related Publication 20170143804A1 · May 25, 2017