Methods relating to hypoglycemic unawareness

• US 7,683,027 B2
• Filed: 10/29/2007
• Issued: 03/23/2010
• Est. Priority Date: 12/27/2002
• Status: Expired due to Fees

• Current Assignee: Enject, Inc.
• Original Assignee: Diobex, Inc.
• Inventors: Green, Daniel T., Henry, Robert R.
• Primary Examiner(s): AUDET, MAURY A
• Application Number:
  US11/927,513
• Publication Number:
  US 20080160071A1
• Time in Patent Office: 876 Days
• Field of Search: None
• US Class Current: 514/7.2
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

Provided are methods of administering glucagon so as to reduce the risk of hypoglycemic unawareness. Also provided are methods of returning hypoglycemic awareness to a subject.

Claims

1. A method of reducing a risk of hypoglycemic unawareness in a subject at risk of hypoglycemic unawareness, said method comprising administering glucagon to said subject in an amount equivalent to a subcutaneous administration of glucagon at a rate of 2 to 16 ng of glucagon per kg of subject weight per minute for a duration of at least one hour, wherein the subject is not hypoglycemic when the glucagon is administered to the subject.

2. The method of claim 1, wherein the glucagon is administered subcutaneously.

3. The method of claim 2, wherein the rate is 3 to 16 ng of glucagon per kg of subject weight per minute.

4. The method of claim 3, wherein the rate is 4 to 8 ng of glucagon per kg of subject weight per minute.

5. The method of claim 3, wherein the duration is at least 4 hours.

6. The method of claim 3, wherein the subject has a blood glucose of no less than 70 mg/dl when the glucagon is administered to the subject.

7. The method of claim 6, wherein the glucagon administered at bedtime.

8. The method of claim 1, wherein the subject has diabetes.

9. The method of claim 8, wherein the diabetes is type I diabetes.

10. The method of claim 8, wherein the diabetes is type II diabetes.

11. The method of claim 8, further comprising the step of administering insulin to the subject.

12. The method of claim 11, wherein the insulin is administered concurrently with the administration of the glucagon.

13. The method of claim 1, further comprising the step of identifying the subject as being at risk of developing hypoglycemic unawareness.

14. The method of claim 13, wherein the step of identifying the subject comprises identifying a subject receiving a treatment for diabetes.

15. A method of returning hypoglycemic awareness to a subject, said method comprising:

identifying a subject suffering from a loss of hypoglycemic awareness; and

administering glucagon to the subject an amount equivalent to a subcutaneous administration of glucagon at a rate of 2 to 16 ng of glucagon per kg of subject weight per minute, wherein the subject is not hypoglycemic when the glucagon is administered to the subject.

16. The method of claim 15, wherein the glucagon is administered subcutaneously.

17. The method of claim 16, wherein the rate is 3 to 16 ng of glucagon per kg of subject weight per minute.

18. The method of claim 15, wherein the subject is diabetic.

19. The method of claim 18, wherein the subject further receives insulin.