Claims for Patent: 10,772,935

Summary for Patent: 10,772,935

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), Howard; Campbell (Yardley, PA), Mann; Alfred (Valencia, CA)
Assignee:	MannKind Corporation (Westlake Village, CA)
Application Number:	16/023,996
Patent Claims:	1. A method of treating hyperglycemia in a patient with diabetes, comprising administering to said patient in need thereof and having a hemoglobin A1C level .gtoreq.6.0% a combination of an ultrarapid acting insulin and a long acting insulin analog, wherein the ultrarapid insulin comprises a dose comprising one or more cartridges of up to 32 units of said ultrarapid insulin formulation administered at mealtime by oral inhalation, and a first dose of the long-acting insulin analog is administered within 6 hours of waking, and optionally, administering a second dose of the long acting insulin at 8 to 14 hours after said first dose of the long-acting insulin, wherein said method further comprises determining the ultrarapid insulin dose for a carbohydrate meal content and administering a predetermined dosage of the ultrarapid acting insulin formulation at mealtime for each daily meal. 2. The method of claim 1, wherein the long acting insulin analog is administered within 3 hours of waking in the morning. 3. The method of claim 1, wherein the long acting insulin analog is insulin detemir or insulin glargine. 4. The method of claim 1, wherein the long acting insulin is insulin glargine. 5. The method of claim 1, wherein the ultrarapid acting insulin comprises a dry powder formulation comprising recombinant human insulin and a 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 6. The method of claim 1, wherein the ultrarapid acting insulin comprises crystalline microparticles of the recombinant insulin and the a 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 7. The method of claim 1, wherein the ultrarapid acting insulin is administered using a dry powder inhaler. 8. The method of claim 1, wherein the hyperglycemia is resultant of diabetes type 2. 9. The method of claim 1, wherein said carbohydrate meal content is .gtoreq.25%, to .ltoreq.200% of a usual meal content as used in determination of the predetermined dose. 10. The method of claim 1, wherein the ultrarapid acting insulin formulation is insulin-FDKP. 11. A method of treating hyperglycemia in a patient in need thereof with a combination of an inhalable ultrarapid acting insulin and an exogenous basal insulin comprising administering the inhalable ultrarapid insulin with a meal, and continuously infusing a short acting insulin with an insulin pump throughout the day. 12. The method of claim 11, wherein the short-acting insulin is a recombinant human insulin or a rapid acting insulin analog.

Details for Patent 10,772,935

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		2038-06-29
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015		2038-06-29
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998		2038-06-29
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	March 31, 1994		2038-06-29
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	May 25, 2018		2038-06-29
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	June 25, 1991		2038-06-29