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Claims for Patent: 7,943,572

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Claims for Patent: 7,943,572

Title:Superior control of blood glucose in diabetes treatment
Abstract: Methods related to the treatment of diabetes and improving the control of blood glucose levels are provided. In particular, methods are provided for effectively reducing postprandial glucose excursions while reducing the incidence of clinically significant late postprandial hypoglycemia by administered an insulin composition in a form suitable for pulmonary administration. Additionally, methods for effectively reducing post-prandial glucose excursions while reducing the incidence of clinically significant late postprandial hypoglycemia by administered an insulin composition in a form suitable for pulmonary administration along with a long-acting basal insulin.
Inventor(s): Cheatham; Wayman Wendell (Columbia, MD), Boss; Anders Hasager (Princeton, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:11/278,381
Patent Claims: 1. A method of reducing postprandial glucose excursions in a patient with an insulin-related disorder comprising: selecting a patient with an insulin-related disorder; administering a long-acting basal insulin; administering an insulin composition comprising fumaryl diketopiperazine in a form suitable for pulmonary administration in proximity to beginning a meal, wherein the patient's total insulin exposure (INS-AUC.sub.0-y, 3<y<6 hours) does not substantially exceed that produced by an appropriate subcutaneous dose of insulin; and reducing the postprandial glucose excursions relative to treatment with the appropriate subcutaneous dose of insulin.

2. The method of claim 1 wherein the risk of late postprandial hypoglycemia is not increased.

3. The method of claim 1, wherein the insulin is complexed with the fumaryl diketopiperazine.

4. The method of claim 1, wherein the insulin composition is administered by inhalation as a dry powder.

5. The method of claim 1, wherein the insulin composition is administered from approximately 10 minutes prior to beginning a meal to approximately 30 minutes after beginning a meal.

6. The method of claim 1, wherein the insulin-related disorder is type I diabetes mellitus.

7. The method of claim 1, wherein the insulin-related disorder is type II diabetes mellitus.

8. The method of claim 1, wherein a mean glucose excursion is at least about 25% less than for an appropriate subcutaneous dose of insulin.

9. The method of claim 1, wherein glucose excursions are measured as AUC.sub.0-240.

10. The method of claim 1, wherein glucose excursions are measured as AUC.sub.0-120.

11. The method of claim 1, wherein glucose excursions are measured as AUC.sub.0-Tx.

12. The method of claim 1, wherein glucose excursions are measured as maximum glucose excursion.

13. The method of claim 12, wherein the maximum glucose excursion does not exceed a blood glucose concentration of 180 mg/dL.

14. The method of claim 12, wherein the maximum glucose excursion does not exceed a premeal baseline blood glucose concentration by more than 59 mg/dL.

15. The method of claim 12, wherein the maximum glucose excursion does not exceed the premeal baseline blood glucose concentration by more than 49 mg/dL.

16. The method of claim 12, wherein the maximum glucose excursion does not exceed the premeal baseline blood glucose concentration by more than 28 mg/dL.
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