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

• US 7,314,859 B2
• Filed: 12/23/2003
• Issued: 01/01/2008
• 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): Tsang; Cecilia J.
• Assistant Examiner(s): AUDET, MAURY A
• Application Number:
  US10/540,803
• Publication Number:
  US 20060160722A1
• Time in Patent Office: 1,470 Days
• Field of Search: 514/3
• 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

1. A method of reducing the risk of insulin-induced htpoglycemia in a diabetes patient who is being treated with insulin, 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/kg/min,

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 administered simultaneously with, or within one minute to four hours after said patient has last been administered insulin.

3. The method of claim 1, wherein said glucagon is administered parenterally by a subcutaneous, intramuscular, or intravenous route.

4. The method of claim 3, wherein said glucagon is a glucagon with a longer duration of action.

5. The method of claim 3, wherein said glucagon is contained in a liposomal formulation.

6. The method of claim 3, wherein said glucagon is contained in a microsphere.

7. The method of claim 1 wherein the administration of glucagon 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 3.00 ng/kg/min.

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