USE OF ULTRARAPID ACTING INSULIN
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.
1 . A method of treating hyperglycemia in a patient with a Body Mass Index (BMI) of over 25 kg/m 2 ; the method comprising:
administering by inhalation an initial dose of an ultra rapid acting insulin formulation taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning the meal.
2 . The method of claim 1 , wherein the patient is currently taking metformin.
3 . The method of claim 2 , wherein the patient is currently taking a GLP-1 agonist.
4 . The method of claim 1 , wherein the patient regularly has a pre-meal blood glucose level greater than 100 mg/dL.
5 . The method of claim 1 , wherein the pre-meal blood glucose of the patient for a next meal is regularly greater than 140 mg/dL.
6 . The method of claim 1 , wherein the initial dose comprises up to 12 units of the ultrarapid acting insulin formulation.
7 . The method of claim 6 , wherein the initial dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation.
8 . The method of claim 1 , wherein the second dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation.
9 . The method of claim 1 , wherein the initial dose is taken at mealtime.
10 . The method of claim 1 , wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal is greater than 140 mg/dL.
11 . The method of claim 1 , wherein the second dose is taken 60-150 minutes after beginning a meal.
12 . The method of claim 11 , wherein the second dose is taken 90-150 minutes after beginning a meal.
13 . The method of claim 1 , wherein the second dose is between 25% to 100% of the initial dose.
14 . The method of claim 1 , wherein the ultrarapid 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.
15 . The method of claim 14 , wherein the ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.
16 . The method of claim 15 , wherein the ultrarapid acting insulin comprises human insulin.
17 . The method of claim 16 , wherein administration is by inhalation.
18 . The method of claim 17 , wherein administration by inhalation comprises use of a breath-powered inhaler.
19 . The method of claim 1 , wherein the pre-meal blood glucose is determined with continuous blood glucose monitoring.