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Claims for Patent: 8,119,593

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Claims for Patent: 8,119,593

Title:Method of treating diabetes type 2 by metformin and an 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): Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Potocka; Elizabeth (Bethel, CT), Boss; Anders Hasager (Princeton, NJ), Petrucci; Richard (New Canaan, CT)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:12/539,459
Patent Claims: 1. A method of treating diabetes type 2, comprising: selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output but not a basal insulin who is in need of improved glycemic control and who would be a candidate for combination treatment with said suppressor of hepatic glucose output and an insulin secretagogue; and instead combining treatment with said suppressor of hepatic glucose output with routinely administering an ultrarapid acting insulin preparation with at least one established meal, wherein the suppressor of hepatic glucose is metformin.

2. The method of claim 1 wherein the patient is further selected for having an insulin resistance at the higher portion of the insulin resistance spectrum.

3. The method of claim 1 wherein the patient is further selected for needing to reduce or avoid weight gain.

4. The method of claim 1 wherein the administering step does not comprise an injection.

5. The method of claim 4 wherein patient is further a candidate for treatment with insulin and is further selected on the basis of being needle-phobic or desiring to avoid frequent injections.

6. The method of claim 1 wherein the insulin secretagogue is a sulfonylurea.

7. The method of claim 1 wherein the patient is further selected for having well or moderately controlled fasting blood glucose.

8. The method of claim 1 wherein the ultrarapid acting insulin preparation is administered by inhalation.

9. The method of claim 8 wherein the ultrarapid acting insulin preparation is a dry powder.

10. The method of claim 9 wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin.

11. The method of claim 9 wherein ultrarapid acting insulin preparation comprises insulin-FDKP.

12. The method of claim 1 wherein the patient is further selected for having an HbA1c level .gtoreq.8.

13. The method of claim 1 wherein the patient is further selected for having an elevated mean amplitude of glucose excursions.

14. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered with each meal containing more than 15 g of carbohydrate.

15. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage sufficient to maximally reduce hepatic glucose output within 60 minutes of administration.

16. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage within the range of 1 to 32 subcutaneous equivalent units.

17. The method of claim 1 wherein peak insulin concentration occurs about 10 minutes to about 30 minutes after administering said ultrarapid insulin preparation.

18. The method of claim 1 wherein peak insulin concentration occurs about 12 minutes to about 14 minutes after administering said ultrarapid insulin preparation.

19. The method of claim 1, wherein a maximal glucose elimination rate occurs about 30 minutes to about 90 minutes after administration.

20. The method of claim 1, wherein a maximal glucose elimination rate occurs about 45 minutes to about 60 minutes after administration.

21. A method of improving glycemic control in a type 2 diabetes patient currently taking a suppressor of hepatic glucose comprising administering to the patient a glycemic control regimen comprising: an ultrarapid acting insulin preparation, added instead of a sulfonylurea, and taken around a mealtime; wherein the patient continues to receive the daily suppressor of hepatic glucose, and the patient is not taking a basal insulin, wherein the suppressor of hepatic glucose is metformin.

22. The method of claim 21, wherein the ultrarapid acting insulin preparation is inhalable.

23. The method of claim 21, wherein the patient has a poorly controlled postprandial blood glucose level.

24. The method of claim 23, wherein the postprandial blood glucose level is at least about 140 mg/dL.

25. The method of claim 23, wherein the postprandial blood glucose level is at least about 180 mg/dL.

26. The method of claim 21, wherein the patient has an HbA1c level less than about 8.4%.

27. The method of claim 21, wherein the patient has well-controlled fasting blood glucose.

28. The method of claim 27, wherein the fasting blood glucose is about 130 mg/dL or lower.

29. The method of claim 27, wherein the fasting blood glucose is about 110 mg/dL or lower.

30. The method of claim 21, wherein the patient has moderately controlled fasting blood glucose.

31. The method of claim 30, wherein the fasting blood glucose is about 192 mg/dL or lower.

32. The method of claim 31, wherein the fasting blood glucose is about 180 mg/dL or lower.

33. The method of claim 31, wherein the fasting blood glucose is about 154 mg/dL or lower.
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