IP Library Granted Patent US 11,013,788
Granted Patent B2
US 11,013,788 · App. 16/385,915 · Granted May 25, 2021

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 11,013,788
App. No.
16/385,915
Granted
May 25, 2021
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 (15)

1. A method of treating a patient with diabetes having a pre-meal blood glucose level greater than 100 mg/dl comprising:

administering a split dose of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of the initial dosage taken 30 to 150 minutes after beginning a meal;

wherein the pre-meal blood glucose level for a next meal is greater than 140 mg/dl.

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

3. The method of claim 2 , wherein the second dose is taken 90-150 minutes after beginning a meal.

4. The method of claim 1 , wherein the pre-meal blood glucose level is greater than 100 mg/dl for at least three pre-meal blood glucose readings taken within 10 days.

5. The method of claim 4 , wherein the pre-meal blood glucose level is greater than 100 mg/dl for at least three pre-meal blood glucose readings taken within 5 days.

6. A method of treating hyperglycemia in a patient whose pre-meal blood glucose is greater than 140 mg/dl, comprising:

administering an initial dose of an ultrarapid acting insulin formulation before a meal or at mealtime, and

administering a secondary dose of the ultrarapid acting insulin formulation 30 to 120 minutes after the initial dose comprising between 10% to 100% of the initial dose, wherein the secondary dose is titrated so that median blood glucose 1 to 2 hours after the secondary dose is less than 180 mg/dl.

7. The method of claim 6 , wherein the secondary dose is administered to a patient in which increasing the dosage of the mealtime dose produces an undesirably lesser, non-proportional reduction in blood glucose as compared to an unincreased mealtime dosage.

8. The method of claim 6 , wherein the 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.

9. The method of claim 8 , wherein the ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

10. The method of claim 9 , wherein the ultrarapid acting insulin formulation comprises human insulin.

11. The method of claim 10 , wherein the ultrarapid acting insulin formulation is administered by inhalation.

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 8, 2019
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD
To: MANNKIND CORPORATION
Reel/Frame 050006/0152 →