IP Library Granted Patent US 11,980,656
Granted Patent B2
US 11,980,656 · App. 17/444,381 · Granted May 14, 2024

Method of treating hypoglycemia events in diabetes treatment

Inventors: Marshall Grant (Newtown, CT); Simon R. Bruce (San Diego, CA); Robert A. Baughman (Brookfield, CT)
Assignee: MannKind Corporation
A61K38/28A61K9/0021A61K9/0075A61K47/545
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Quick Facts
Patent No.
US 11,980,656
App. No.
17/444,381
Granted
May 14, 2024
Kind
B2
Abstract

An ultra-rapid acting insulin composition and method for treating hyperglycemia in patients with diabetes are disclose. The composition is an inhalable dry powder composition comprising fumaryl diketopiperazine and insulin for pulmonary delivery, which significantly reduces the rates of hypoglycemic events in patients in patients on mealtime insulin therapy.

Claims (9)

1. A method of treating diabetes comprising:

a. selecting a patient being treated for diabetes type 1 with an insulin-pump;

b. replacing the insulin pump with an injectable therapy comprising a long-acting insulin administered upon waking; and

c. administering an inhalable insulin composition comprising a therapeutically effective dose of a pharmaceutical composition comprising insulin and fumaryl diketopiperazine to the patient at mealtime.

2. The method of claim 1 , wherein the pharmaceutical composition is administered using a dry powder inhaler.

3. The method of claim 2 , wherein the dry powder inhaler is for oral inhalation.

4. The method of claim 1 , wherein the long-acting basal insulin is insulin glargine, insulin aspart or insulin degludec.

5. The method of claim 4 , wherein the long-acting basal insulin is administered in the morning prior to a meal.

6. The method of claim 1 , wherein the inhalable insulin composition is provided in a single unit dose cartridge comprising 4 units, 8 units, or 12 units of insulin per dose.

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 Apr 25, 2024
From: GRANT, MARSHALL; BAUGHMAN, ROBERT; BRUCE, SIMON R.
To: MANNKIND CORPORATION
Reel/Frame 067223/0922 →
Continuity (11)
Division 16449308 · Jun 21, 2019
Continuation In Part 15910876 · Mar 2, 2018
Division 14102383 · Dec 10, 2013
Continuation 13351855 · Jan 17, 2012
Division 12539459 · Aug 11, 2009
Provisional Application 62688670 · Jun 22, 2018
Provisional Application 61138863 · Dec 18, 2008
Provisional Application 61097495 · Sep 16, 2008
Provisional Application 61097516 · Sep 16, 2008
Provisional Application 61087943 · Aug 11, 2008
Related Publication 20210361746A1 · Nov 25, 2021