Claims for Patent: 10,307,464

Summary for Patent: 10,307,464

Title:	Use of ultrarapid acting insulin
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.
Inventor(s):	Boss; Anders Hasager (Princeton, NJ), Petrucci; Richard (New Canaan, CT)
Assignee:	MannKind Corporation (Westlake Village, CA)
Application Number:	15/300,239
Patent 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.

Details for Patent 10,307,464

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	October 28, 1982		2040-04-01
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015		2040-04-01
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998		2040-04-01
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	March 31, 1994		2040-04-01
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	May 25, 2018		2040-04-01