USE OF ULTRARAPID ACTING INSULIN Patent Application WO/2015/
Oct 2, 2015 3:43:12 GMT -5
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Document Type and Number: WIPO Patent Application WO/2015/148905
Kind Code: A1
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.
Assignee: MANNKIND CORPORATION (28903 North Avenue Paine, Valencia, CA, 91355, US)
Claims:
What is claimed is:
1 . A method of treating higher than targeted pre-meal blood glucose 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 for a next meal had been regularly greater than desired.
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 desired comprises pre-meal blood glucose levels of greater than 120 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 greater than 120 mg/dl.
6. The method of claim 4, wherein said regularly greater than desired 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.
7. The method of claim 1 , wherein the pre-meal blood glucose is greater than 140 mg/dl.
8. The method of claim 1 , wherein the pre-meal blood glucose is regularly greater than desired when at least three pre-meal blood glucose readings are taken within 10 days and are greater than 100 mg/dl.
9. The method of claim 8, wherein the pre-meal blood glucose is regularly greater than desired when at least three pre-meal blood glucose readings are taken within 5 days and are greater than 100 mg/dl .
10. A method of treating hyperglycemia comprising: administering a secondary dose of an ultra rapid acting insulin formulation 30 to 120 minutes after a 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.
1 1 . The method of claim 10 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.
12. The method of any of the preceding claims 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.
13. The method of any of the preceding claims wherein the ultra rapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.
14. The method of any of the preceding claims wherein the ultra rapid acting insulin comprises human insulin.
15. The method of any of the preceding claims wherein administration is by inhalation.
16. The method of any of the preceding claims wherein administration is by pulmonary inhalation.
Document Type and Number: WIPO Patent Application WO/2015/148905
Kind Code: A1
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.
Assignee: MANNKIND CORPORATION (28903 North Avenue Paine, Valencia, CA, 91355, US)
Claims:
What is claimed is:
1 . A method of treating higher than targeted pre-meal blood glucose 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 for a next meal had been regularly greater than desired.
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 desired comprises pre-meal blood glucose levels of greater than 120 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 greater than 120 mg/dl.
6. The method of claim 4, wherein said regularly greater than desired 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.
7. The method of claim 1 , wherein the pre-meal blood glucose is greater than 140 mg/dl.
8. The method of claim 1 , wherein the pre-meal blood glucose is regularly greater than desired when at least three pre-meal blood glucose readings are taken within 10 days and are greater than 100 mg/dl.
9. The method of claim 8, wherein the pre-meal blood glucose is regularly greater than desired when at least three pre-meal blood glucose readings are taken within 5 days and are greater than 100 mg/dl .
10. A method of treating hyperglycemia comprising: administering a secondary dose of an ultra rapid acting insulin formulation 30 to 120 minutes after a 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.
1 1 . The method of claim 10 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.
12. The method of any of the preceding claims 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.
13. The method of any of the preceding claims wherein the ultra rapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine.
14. The method of any of the preceding claims wherein the ultra rapid acting insulin comprises human insulin.
15. The method of any of the preceding claims wherein administration is by inhalation.
16. The method of any of the preceding claims wherein administration is by pulmonary inhalation.