Method of treating diabetes type 2 by administering ultrarapid acting insulin

• US 8,623,817 B2
• Filed: 01/17/2012
• Issued: 01/07/2014
• Est. Priority Date: 08/11/2008
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Richardson, Peter, Baughman, Robert A., Potocka, Elizabeth, Boss, Anders Hasager, Petrucci, Richard
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US13/351,855
• Publication Number:
  US 20120115777A1
• Time in Patent Office: 721 Days
• Field of Search: None
• US Class Current: 514/5.9
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 47/545 Heterocyclic compounds A61K47/558 takes precedence
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

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 ≧

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.