Claims for Patent: 9,943,571

Summary for Patent: 9,943,571

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):	Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Potocka; Elizabeth (Bethel, CT), Boss; Anders Hasager (Princeton, NJ), Petrucci; Richard (New Canaan, CT)
Assignee:	MannKind Corporation (Westlake Village, CA)
Application Number:	14/102,383
Patent Claims:	1. A method of starting treatment with a prandial insulin using an ultrarapid acting insulin (URAI) preparation comprising administering to a patient in need thereof a dose of an ultrarapid acting insulin preparation in proximity to the beginning of a daily meal wherein the dose is up to 90 units of said URAI, wherein the initial dose administered to said patient is up to 12 units of said URAI, wherein said URAI is not administered by subcutaneous injection. 2. The method of claim 1 wherein the initial dosage is 2-4 units. 3. The method of claim 1 wherein the initial dosage is 1-2 units. 4. The method of claim 1 wherein 2-hour post-prandial blood glucose is measured for said daily meal. 5. The method of claim 4 comprising measuring blood glucose at the daily meal on at least three days within one week. 6. The method of claim 5 comprising measuring blood glucose at the daily meal on three consecutive days. 7. The method of claim 5 comprising measuring blood glucose at the daily meal on seven consecutive days. 8. The method of claim 5 further comprising titrating up the dosage of the URAI preparation by increasing the dosage for the daily meal by the amount of the initial dosage if 2-hour post-prandial median glucose is >110. 9. The method of claim 8 wherein the URAI comprises a diketopiperazine. 10. The method of claim 9 wherein the diketopiperazine is at least one of 3,6-di(succinyl-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(maleyl-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(glutaryl-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(malonyl-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(oxalyl-4-aminobutyl)-2, 5-diketopiperazine, and 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 11. The method of claim 10 wherein the diketopiperazine is 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine. 12. The method of claim 11 wherein the URAI comprises human insulin. 13. The method of claim 12 wherein the URAI is a dry powder. 14. The method of claim 1 wherein the URAI preparation is not administered by injection. 15. The method of claim 14 wherein the URAI preparation is administered by inhalation. 16. The method of claim 15 wherein the URAI preparation is administered by inhalation into the lungs. 17. The method of claim 1 wherein the initial dosage is provided in a unit dose cartridge. 18. The method of claim 17, wherein the unit dose cartridge comprises 4, 8, or 12 units. 19. The method of claim 18, wherein the unit dose cartridge comprises 4 units. 20. The method of claim 18, wherein the unit dose cartridge comprises 8 units. 21. The method of claim 18, wherein the unit dose cartridge comprises 12 units. 22. The method of claim 1 wherein the URAI preparation is insulin-FDKP. 23. A method of starting treatment with a prandial insulin using an ultrarapid acting insulin (URAI) preparation comprising 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine and human insulin, said method comprising prandially administering by inhalation to a patient in need thereof an initial dosage of the URAI preparation of 2-4 units.