Compositions and methods for the prevention and control of insulin-induced hypoglycemia

• US 20080096801A1
• Filed: 12/21/2007
• Published: 04/24/2008
• Est. Priority Date: 12/27/2002
• Status: Active Grant

• Current Assignee: Diobex, Inc.
• Original Assignee: Diobex, Inc.
• Inventors: Henry, Robert, Green, Daniel
• Granted Patent: US 7,642,232 B2
• Time in Patent Office: Days
• US Class Current: 514/5.9
• 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: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices 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: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• 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

Pharmaceutical composition comprising both insulin and glucagon can be administered to control and treat diabetes while reducing or eliminating the risk of insulin-induced hypoglycemia.

Claims

2. A method of treating diabetes in a human or other mammal, said method comprising the steps of administering insulin in an amount therapeutically effective for the control of diabetes and administering glucagon in an amount therapeutically effective for the prevention of hypoglycemia, wherein said administering steps are conducted within twelve hours of each other.

3. The method of claim 2, wherein said insulin and glucagon are administered separately.

4. The method of claim 2, wherein insulin and glucagon are administered within one minute to four hours of each other.

7. The method of claim 2, wherein said insulin is administered parenterally and said glucagon is administered by a route of administration selected from the group consisting of oral administration, ocular administration, nasal administration, pulmonary administration, parenteral administration, and transdermal administration.

8. The method of claim 7, wherein said glucagon is administered transdermally.

9. The method of claim 7, wherein said glucagon is a glucagon with a longer duration of action.

10. The method of claim 2, comprising administering a formulation comprising both insulin and glucagon.

11. The method of claim 7, wherein said glucagon is contained in a liposomal formulation.

12. The method of claim 7, wherein said glucagon is contained in a microsphere.

13. The method of claim 2, wherein said insulin is administered by a route of administration selected from the group consisting of parenteral administration, oral administration, ocular administration, nasal administration, pulmonary administration, and transdermal administration, and said glucagon is administered by a route of administration selected from the group consisting of parenteral administration, oral administration, ocular administration, nasal administration, pulmonary administration, and transdermal administration.

14. The method of claim 13, wherein said both insulin and glucagon are administered parenterally.

15. The method of claim 14, wherein said insulin and glucagon are contained in a pump that controls administration of the drugs to a patient.

16. The method of claim 15 wherein the insulin and glucagon are contained in separate chambers of the pump.

17. The method of claim 16 wherein the pump is programmed to deliver glucagon daily.

18. The method of claim 16 wherein the pump is programmed to administer glucagon is administered within four hours after said patient has last been administered insulin.

19. The method of claim 18 wherein the pump is programmed to administer glucagon and insulin simultaneously.

5. A method of preventing hypoglycemia in a diabetes patient who is being treated with insulin and who is not suffering hypoglycemic symptoms, which method comprises administering glucagon to said patient in an amount therapeutically effective for the prevention of hypoglycemia.

6. The method of claim 5, wherein said glucagon is administered simultaneously with, or within one minute to four hours after said patient has last been administered insulin.

20. An infusion pump containing both insulin and glucagon.

1. A pharmaceutical formulation comprising insulin and glucagon in amounts therapeutically effective for the control of diabetes and the prevention of hypoglycemia in a human or other mammal.

21. The pump of claim 20 wherein the insulin and glucagon are contained in separate chambers of the pump.

22. The pump of claim 21 wherein the weight of glucagon in the pump is less than 5% of the weight of insulin in the pump.

23. The pump of claim 21 that is programmed to administer glucagon simultaneously with or within four hours after administration of insulin by the pump.

22-1. The pump of claim 21 wherein the weight of glucagon in the pump is 0.09-112.3% of the weight of insulin.