Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content

• US 8,258,095 B2
• Filed: 08/11/2009
• Issued: 09/04/2012
• Est. Priority Date: 08/11/2008
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Boss, Anders Hasager, Petrucci, Richard, Howard, Campbell, Mann, Alfred
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US12/539,499
• Publication Number:
  US 20100035795A1
• Time in Patent Office: 1,120 Days
• Field of Search: None
• US Class Current: 514/6.8
• 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 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 ≧

25% to ≦

250% of the individual'"'"'s usual meal content, and the standard dosage is not adjusted when a meal is consumed that varies from ≧

25% to ≦

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 ≧

25% of a usual meal content as used in predetermination of the standard dose.

9. The method of claim 8 wherein meal content is ≧

50% of a usual meal content as used in predetermination of the standard dose.

10. The method of claim 1 wherein meal content is ≦

200% of a usual meal content as used in predetermination of the standard dose.

11. The method of claim 10 wherein meal content is ≦

150% of a usual meal content as used in predetermination of the standard dose.