Claims for Patent: 10,046,031

Summary for Patent: 10,046,031

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:	15/421,743
Patent Claims:	1. A method of controlling glycemia related to a daily meal for a patient with delayed or prolonged nutrient absorption comprising the steps of: selecting a patient with delayed nutrient absorption; administering to the patient with delayed nutrient absorption 50% to 75% of a predetermined dosage of an ultrarapid acting insulin formulation at mealtime for the daily meal; and administering the remainder of the predetermined dosage 30 to 120 minutes after beginning the daily meal. 2. The method of claim 1 wherein the ultrarapid acting insulin formulation comprises a diketopiperazine. 3. The method of claim 2 wherein said diketopiperazine comprises at least one of 3,6-di(succinyl-4-aminobutyl)-diketopiperazine, 3,6-di(maleyl-4-aminobutyl)-diketopiperazine, 3,6-di(glutaryl-4-aminobutyl)-diketopiperazine, 3,6-di(malonyl-4-aminobutyl)-diketopiperazine, 3,6-di(oxalyl-4-aminobutyl)-diketopiperazine, and 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 4. The method of claim 3, wherein said diketopiperazine comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 5. The method of claim 1 wherein the nutrient absorption is delayed and is related to a disease state. 6. The method of claim 1 wherein the nutrient absorption is delayed and is related to a meal content high in fat or fiber. 7. The method of claim 1 wherein the nutrient absorption is prolonged and is related to a prolonged meal. 8. The method of claim 1 wherein the ultrarapid acting insulin is administered by inhalation into the lungs. 9. The method of claim 8, wherein the ultrarapid acting insulin is administered with a unit dose inhaler. 10. The method of claim 9, wherein said administration comprises a dose of between 7.5 IU to 120 IU. 11. The method of claim 10, wherein said administration comprises a dose of between 15 IU to 90 IU. 12. The method of claim 11, wherein said administration comprises a dose of greater than 24 IU. 13. The method of claim 1 wherein 50% to 75% of the predetermined dosage of the ultrarapid acting insulin formulation is administered 10 minutes before to 30 minutes after beginning the daily meal.