# US 10,307,464 B2 · Use of ultrarapid acting insulin

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- Number: US 10,307,464 B2
- Document ID: US10307464B2
- Status: Granted
- Kind: B2
- Application number: 15/300,239
- Filed: 2015-03-27
- Published: 2017-07-06
- Granted: 2019-06-04
- Earliest claimed: 2015-03-27
- Assignees: MannKind Corporation
- Applicants: MannKind Corporation
- Inventors: Anders Hasager Boss; Richard Petrucci
- Web page: https://patentgrep.com/patent/US10307464B2

## CPC

- A61K 38/28: Insulins
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- 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 pre-meal hyperglycemia in a patient in need of treatment who is monitored for pre-meal blood glucose levels for 10 days comprising: regularly administering a split dose of an ultra rapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of the initial dosage taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose level for a next meal had been regularly greater than 120 mg/dl.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second dose is taken 60-150 minutes after beginning a meal.

### Claim 3 (depends on 2)

The method of claim 2, wherein the second dose is taken 90-150 minutes after beginning a meal.

### Claim 4 (depends on 1)

The method of claim 1, wherein said regularly greater than 120 mg/dl comprises pre-meal blood glucose levels of greater than 140 mg/dl for a majority of the pre-meal blood glucose tests within a given time period.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pre-meal blood glucose is regularly greater than 150 mg/dl.

### Claim 6 (depends on 5)

The method of claim 5, wherein the pre-meal blood glucose is regularly greater than 160 mg/dl.

### Claim 7

A method of treating hyperglycemia in a patient whose pre-meal blood glucose is greater than 140 mg/dl, comprising: administering a mealtime dose, then administering a secondary dose of an ultra rapid acting insulin formulation 30 to 120 minutes after the mealtime dose comprising between 10% to 100% of an initial dose, wherein the secondary dose is titrated so that median blood glucose 1 to 2 hours after the secondary dose is less than 180 mg/dl.

### Claim 8 (depends on 7)

The method of claim 7 wherein the secondary dose is administered to a patient in which increasing the dosage of the mealtime dose produces an undesirably lesser, non-proportional reduction is blood glucose as compared to an unincreased mealtime dosage.

### Claim 9 (depends on 7)

The method of claim 7, wherein the ultra rapid acting insulin formulation comprises 3,6-di(succinyl-4-aminobutyl)-, 3,6-di(maleyl-4-aminobutyl)-, 3,6-di(glutaryl-4-aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-aminobutyl)-, or 3,6-di(fumaryl-4-aminobutyl)-2, 5-diketopiperazine.

### Claim 10 (depends on 9)

The method of claim 9, wherein the ultra rapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.

### Claim 11 (depends on 10)

The method of claim 10, wherein the ultra rapid acting insulin comprises human insulin.

### Claim 12 (depends on 11)

The method of claim 11, wherein administration is by inhalation.