# US 11,998,591 B2 · Method of treating diabetes type 2 by administering ultrarapid acting insulin

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,998,591 B2
- Document ID: US11998591B2
- Status: Granted
- Kind: B2
- Application number: 17/105,399
- Filed: 2020-11-25
- Published: 2021-05-13
- Granted: 2024-06-04
- Earliest claimed: 2008-08-11
- Assignees: MannKind Corporation
- Applicants: MannKind Corporation
- Inventors: Peter Richardson; Robert A. Baughman; Elizabeth Potocka; Anders Hasager Boss; Richard Petrucci
- Web page: https://patentgrep.com/patent/US11998591B2

## CPC

- A61K 38/28: Insulins
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 47/545: {Heterocyclic compounds (A61K47/558 takes precedence)}
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 3)

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

### Claim 5 (depends on 1)

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

### Claim 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.

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 7)

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

### Claim 9 (depends on 8)

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

### Claim 10 (depends on 9)

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

### Claim 11 (depends on 6)

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