Use of ultrarapid acting insulin

• US 10,307,464 B2
• Filed: 03/27/2015
• Issued: 06/04/2019
• Est. Priority Date: 03/28/2014
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Boss, Anders Hasager, Petrucci, Richard
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US15/300,239
• Publication Number:
  US 20170189492A1
• Time in Patent Office: 1,530 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

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

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.

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

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

4. 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.

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

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

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.

8. 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.

9. 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.

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

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

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