IP Library Granted Patent US 11,998,591
Granted Patent B2
US 11,998,591 · App. 17/105,399 · Granted Jun 4, 2024

Method of treating diabetes type 2 by administering ultrarapid acting insulin

Inventors: Peter Richardson (Ringoes, NJ); Robert A. Baughman (Brookfield, CT); Elizabeth Potocka (Cambridge, MA); Anders Hasager Boss (Princeton, NJ); Richard Petrucci (Tampa, FL)
Assignee: MannKind Corporation
A61K38/28A61K9/0021A61K9/0075A61K47/545
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Quick Facts
Patent No.
US 11,998,591
App. No.
17/105,399
Granted
Jun 4, 2024
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 (13)

1. A method of treating diabetes type 2 in a subject with well or moderately controlled fasting blood glucose (FBG) but poorly controlled post-prandial glucose (PPG), and in need of avoiding weight gain, comprising:

selecting said patient with diabetes type 2 currently being treated with metformin but not a basal insulin who is in need of improved glycemic control and who would be a candidate for combination treatment with said metformin and an insulin secretagogue, said patient having an HbA1c level less than or equal to 8.4%; and

instead combining treatment with said metformin with routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein said treatment results in reduced weight gain as compared to metformin treatment alone.

2. The method of claim 1 , wherein the ultrarapid acting insulin preparation is administered by inhalation.

3. The method of claim 2 , wherein the ultrarapid acting insulin preparation is a dry powder.

4. The method of claim 3 , wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin.

5. The method of claim 1 , further comprising administration of a GLP-1 agonist.

6. A method of treating diabetes type 2 in a subject with well or moderately controlled fasting blood glucose (FBG) but poorly controlled post-prandial glucose (PPG), and in need of avoiding weight gain, comprising: selecting said patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, said patient having an HbA1c level less than or equal to 8.4%, wherein said treatment results in reduced weight gain as compared to treatment with said suppressor of hepatic glucose output and insulin secretagogue.

7. The method of claim 6 , wherein the insulin secretagogue is a sulfonylurea.

8. The method of claim 7 , wherein the URAI preparation is not administered by injection.

9. The method of claim 8 , wherein the URAI preparation is administered by inhalation.

10. The method of claim 9 , wherein the URAI preparation is administered by inhalation into the lungs.

11. The method of claim 6 , further comprising administration of a GLP-1 agonist.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072444/0525 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 25, 2021
From: RICHARDSON, PETER; BAUGHMAN, ROBERT A.; POTOCKA, ELIZABETH; BOSS, ANDERS HASAGER; PETRUCCI, RICHARD
To: MANNKIND CORPORATION
Reel/Frame 056340/0420 →
Continuity (9)
Continuation 15910876 · Mar 2, 2018
Division 14102383 · Dec 10, 2013
Continuation 13351855 · Jan 17, 2012
Division 12539459 · Aug 11, 2009
Provisional Application 61138863 · Dec 18, 2008
Provisional Application 61097516 · Sep 16, 2008
Provisional Application 61097495 · Sep 16, 2008
Provisional Application 61087943 · Aug 11, 2008
Related Publication 20210138040A1 · May 13, 2021