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Last Updated: March 29, 2024

Details for Patent: 9,597,374


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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 (Valencia, CA)
Filing Date:Jan 25, 2012
Application Number:13/357,821
Claims:1. A method of controlling glycemia related to a daily meal by administering a total insulin dosage comprising an initial predetermined dose, wherein the total insulin dosage is adjusted to the glycemic load of the meal consumed comprising the steps of: administering an initial predetermined dose of an ultrarapid acting insulin formulation at mealtime for the daily meal, wherein the initial predetermined dose is a standard dose for the daily meal; determining postprandial blood glucose 1 to 2 hours after beginning the daily meal; and if the postprandial blood glucose is >140 mg/dl administering a supplemental dose of the ultrarapid acting insulin formulation wherein the supplemental dose is 25% to 100% of the initial dose.

2. The method of claim 1 wherein the ultrarapid acting insulin formulation is insulin-fumaryl diketopiperazine (FDKP).

3. A method of controlling glycemia related to a daily meal by administering a total insulin dosage comprising an initial predetermined dose, wherein the total insulin dosage is adjusted to the glycemic load of the meal consumed, such that postprandial blood glucose 1 to 2 hours after the daily meal is constrained to 200 mg/dl, comprising the steps of: administering an initial predetermined dose of an ultrarapid acting insulin formulation at mealtime for the daily meal, wherein the initial predetermined dose is a standard dose for the daily meal; determining postprandial blood glucose 1 to 2 hours after beginning the daily meal; and administering a supplemental dose of the ultrarapid acting insulin formulation wherein the supplemental dose is 25% to 100% of the initial dose.

4. The method of claim 3 wherein the postprandial blood glucose is constrained to 180 mg/dl.

5. The method of claim 4 wherein the postprandial blood glucose is constrained to 140 mg/dl.

6. The method of claim 3 wherein the ultrarapid acting insulin formulation is insulin-FDKP.

7. A method of controlling glycemia related to one or more daily meals in an individual with diabetes by administering a total insulin dosage comprising an initial predetermined dose, comprising the steps of: administering an initial predetermined dose of an ultrarapid acting insulin formulation at mealtime for the daily meal, wherein the initial predetermined dose is a standard dose for the daily meal; and, administering a supplemental dose of the ultrarapid acting insulin formulation 30 to 120 minutes after beginning the meal.

8. The method of claim 7 further comprising: determining postprandial blood glucose 1 to 2 hours after beginning the daily meal; and, administering the supplemental dose only if the postprandial blood glucose is >140 mg/dl, wherein the supplemental dose of the ultrarapid acting insulin formulation is 25% to 100% of the initial dose.

9. The method of claim 8 wherein the ultrarapid acting insulin formulation is insulin-FDKP.

10. The method of claim 7, wherein the individual is an individual with delayed or prolonged nutrient absorption wherein: the initial dose is 50% to 75% of a dosage of ultrarapid acting insulin formulation for the meal if the dosage were to be given as a single dose.

11. The method of claim 10, wherein the supplemental dose is the remainder of the dosage of ultrarapid acting insulin formulation for the meal if the dosage were to be given as a single dose.

12. The method of claim 10 wherein the ultrarapid acting insulin formulation is insulin-FDKP.

13. The method of claim 7 wherein the individual has delayed or prolonged nutrient absorption.

14. The method of claim 13 wherein 50% to 75% of the predetermined dosage of an ultrarapid acting insulin formulation is administered at the daily meal; and the remainder of the predetermined dosage is administered 30 to 120 minutes after beginning the daily meal.

15. The method of claim 14 wherein the ultrarapid acting insulin formulation is insulin-FDKP.

16. The method of claim 14 wherein the nutrient absorption is delayed and is related to a disease state.

17. The method of claim 14 wherein the nutrient absorption is delayed and is related to a meal content high in fat or fiber.

18. The method of claim 14 wherein the nutrient absorption is prolonged and is related to a prolonged meal.

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