IP Library Granted Patent US 10,772,935
Granted Patent B2
US 10,772,935 · App. 16/023,996 · Granted Sep 15, 2020

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 10,772,935
App. No.
16/023,996
Granted
Sep 15, 2020
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 (14)

1. A method of treating hyperglycemia in a patient with diabetes, comprising

administering to said patient in need thereof and having a hemoglobin A1C level ≥6.0% a combination of an ultrarapid acting insulin and a long acting insulin analog,

wherein the ultrarapid insulin comprises a dose comprising one or more cartridges of up to 32 units of said ultrarapid insulin formulation administered at mealtime by oral inhalation, and a first dose of the long-acting insulin analog is administered within 6 hours of waking, and optionally, administering a second dose of the long acting insulin at 8 to 14 hours after said first dose of the long-acting insulin, wherein said method further comprises determining the ultrarapid insulin dose for a carbohydrate meal content and administering a predetermined dosage of the ultrarapid acting insulin formulation at mealtime for each daily meal.

2. The method of claim 1 , wherein the long acting insulin analog is administered within 3 hours of waking in the morning.

3. The method of claim 1 , wherein the long acting insulin analog is insulin detemir or insulin glargine.

4. The method of claim 1 , wherein the long acting insulin is insulin glargine.

5. The method of claim 1 , wherein the ultrarapid acting insulin comprises a dry powder formulation comprising recombinant human insulin and a 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

6. The method of claim 1 , wherein the ultrarapid acting insulin comprises crystalline microparticles of the recombinant insulin and the a 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

7. The method of claim 1 , wherein the ultrarapid acting insulin is administered using a dry powder inhaler.

8. The method of claim 1 , wherein the hyperglycemia is resultant of diabetes type 2.

9. The method of claim 1 , wherein said carbohydrate meal content is ≥25%, to ≤200% of a usual meal content as used in determination of the predetermined dose.

10. The method of claim 1 , wherein the ultrarapid acting insulin formulation is insulin-FDKP.

11. A method of treating hyperglycemia in a patient in need thereof with a combination of an inhalable ultrarapid acting insulin and an exogenous basal insulin comprising administering the inhalable ultrarapid insulin with a meal, and continuously infusing a short acting insulin with an insulin pump throughout the day.

12. The method of claim 11 , wherein the short-acting insulin is a recombinant human insulin or a rapid acting insulin analog.

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 Nov 8, 2018
From: BOSS, ANDERS HASAGER; PETRUCCI, RICHARD; HOWARD, CAMPBELL; MANN, ALFRED
To: MANNKIND CORPORATION
Reel/Frame 047455/0392 →