IP Library Granted Patent US 10,307,464
Granted Patent B2
US 10,307,464 · App. 15/300,239 · Granted Jun 4, 2019

Use of ultrarapid acting insulin

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Quick Facts
Patent No.
US 10,307,464
App. No.
15/300,239
Granted
Jun 4, 2019
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 (12)

1. A method of treating pre-meal hyperglycemia in a patient in need of treatment who is monitored for pre-meal blood glucose levels for 10 days comprising: regularly administering a split dose of an ultra rapid 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 when pre-meal blood glucose level for a next meal had been regularly greater than 120 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 said regularly greater than 120 mg/dl comprises pre-meal blood glucose levels of greater than 140 mg/dl for a majority of the pre-meal blood glucose tests within a given time period.

5. The method of claim 1 , wherein the pre-meal blood glucose is regularly greater than 150 mg/dl.

6. The method of claim 5 , wherein the pre-meal blood glucose is regularly greater than 160 mg/dl.

7. A method of treating hyperglycemia in a patient whose pre-meal blood glucose is greater than 140 mg/dl, comprising: administering a mealtime dose, then administering a secondary dose of an ultra rapid acting insulin formulation 30 to 120 minutes after the mealtime dose comprising between 10% to 100% of an 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.

8. The method of claim 7 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 is blood glucose as compared to an unincreased mealtime dosage.

9. The method of claim 7 , wherein the ultra rapid 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.

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

11. The method of claim 10 , wherein the ultra rapid acting insulin comprises human insulin.

12. The method of claim 11 , wherein administration is 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 Sep 28, 2016
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD
To: MANNKIND CORPORATION
Reel/Frame 039884/0288 →