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Claims for Patent: 8,258,095

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Claims for Patent: 8,258,095

Title:Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content
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)
Application Number:12/539,499
Patent Claims: 1. A method of controlling glycemia related to one or more daily meals in an individual with diabetes without adjusting an insulin dose for meal content comprising the step of administering a standard dosage of an ultrarapid acting insulin formulation at a mealtime for one or more of the daily meals, wherein, for any given daily meal, the standard dosage for the daily meal has been predetermined based on said individual's usual meal content for the daily meal, and wherein, at least occasionally, content of the daily meal varies from .gtoreq.25% to .ltoreq.250% of the individual's usual meal content, and the standard dosage is not adjusted when a meal is consumed that varies from .gtoreq.25% to .ltoreq.250% of the individual's usual meal content as used in the determination of the standard dosage.

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

3. The method of claim 1 wherein a standard dosage is administered at each mealtime.

4. The method of claim 1 wherein a single predetermined dosage is used for each mealtime.

5. The method of claim 1 wherein a predetermined dosage is set for each mealtime.

6. The method of claim 1 wherein meal content is assessed as glycemic load.

7. The method of claim 1 wherein meal content is assessed as caloric content.

8. The method of claim 1 wherein meal content is .gtoreq.25% of a usual meal content as used in predetermination of the standard dose.

9. The method of claim 8 wherein meal content is .gtoreq.50% of a usual meal content as used in predetermination of the standard dose.

10. The method of claim 1 wherein meal content is .ltoreq.200% of a usual meal content as used in predetermination of the standard dose.

11. The method of claim 10 wherein meal content is .ltoreq.150% of a usual meal content as used in predetermination of the standard dose.
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