Method of treating diabetes type 2 by administering ultrarapid acting insulin

Patent metadata

Field	Value
Publication number	US-11998591-B2
Application number	US-202017105399-A
Country	US
Kind code	B2
Filing date	Nov 25, 2020
Priority date	Aug 11, 2008
Publication date	Jun 4, 2024
Grant date	Jun 4, 2024

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.

First claim

What is claimed is:

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.

Assignees

• Mannkind Corp

Inventors

• Richardson Peter
• Baughman Robert A
• Potocka Elizabeth
• Boss Anders Hasager
• Petrucci Richard

Classifications

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K38/28 Primary

  Insulins · CPC title

• A61K9/0021

  Intradermal administration, e.g. through microneedle arrays or needleless injectors · CPC title

• A61K9/0075

  for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles · CPC title

• A61K47/545

  Heterocyclic compounds (A61K47/558 takes precedence) · CPC title