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Claims for Patent: 8,623,817

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Claims for Patent: 8,623,817

Title:Method of treating diabetes type 2 by administering 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:13/351,855
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 and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin preparation with at least one established meal.

2. The method of claim 1 wherein treatment with the suppressor of hepatic glucose output is also discontinued.

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

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

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

6. The method of claim 5 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.

7. The method of claim 1 wherein the suppressor of hepatic glucose output is metformin.

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

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

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

11. The method of claim 10 wherein the ultrarapid acting insulin preparation is a dry powder.

12. The method of claim 11 wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin.

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

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

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

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

17. 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.

18. 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.

19. The method of claim 1 wherein the ultrarapid acting insulin preparation comprises an insulin analog.

20. The method of claim 19 wherein the insulin analog is insulin aspart, insulin glulisine, or insulin lispro.
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