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

• US 7,642,232 B2
• Filed: 12/21/2007
• Issued: 01/05/2010
• Est. Priority Date: 12/27/2002
• Status: Expired due to Fees

• Current Assignee: Diobex, Inc.
• Original Assignee: Diobex, Inc.
• Inventors: Green, Daniel T., Henry, Robert R.
• Primary Examiner(s): AUDET, MAURY A
• Application Number:
  US11/963,584
• Publication Number:
  US 20080096801A1
• Time in Patent Office: 746 Days
• Field of Search: None
• US Class Current: 514/1.1
• 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

1. A method of reducing the risk of hypoglycemia in a diabetes patient who is being treated with insulin or an insulin secretagogue, which method comprises administering to the patient an amount of glucagon that results in a plasma glucagon level in the range achieved by intravenous infusion of glucagon at a rate that is not less than 0.10 ng/kg/min and not more than 5.00 ng/kglmin, wherein glucagon is administered daily as part of a diabetes treatment regimen, and wherein said patient is not suffering hypoglycemic symptoms and has a blood glucose level of from 70-110 mg/dL when said glucagon is administered.

2. The method of claim 1, wherein said glucagon is contained in a device that controls administration of the drug to a patient.

3. The method of claim 2 wherein the device is a pump.

4. The method of claim 3 wherein the pump is programmed to deliver glucagon daily.

5. The method of claim 3 wherein the pump is programmed to administer glucagon is administered within four hours after said patient has last been administered insulin.

6. The method of claim 2 wherein the device is a transdermal delivery device.

7. The method of claim 1, wherein both insulin and glucagon are administered parenterally.

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

9. The method of claim 8 wherein the secretagogue is acetohexamide, chlorpropamide, tolazamide, tolbutamide, glimepiride, glipizide, or glyburide.

10. The method of claim 1 wherein the secretagogue is a meglitinide.

11. The method of claim 10 wherein the secretagogue is nateglinide or repaglinide.

12. The method of claim 1 wherein glucagon is administered daily at bedtime.

13. The method of claim 7 wherein the patient is unable to sense low blood glucose accurately due to hypoglycemic unawareness.