Compositions and methods for reducing hyperglycemia and treating diabetes

• US 10,639,328 B1
• Filed: 05/31/2019
• Issued: 05/05/2020
• Est. Priority Date: 03/27/2019
• Status: Active Grant

• Current Assignee: Auxulin Pharmaceuticals Inc., College of William & Mary
• Original Assignee: Auxulin Pharmaceuticals Inc., College of William & Mary
• Inventors: Ritz, Thomas, Ritz, Gary, McDevitt, Jason P.
• Primary Examiner(s): Cabral, Robert S
• Application Number:
  US16/428,388
• Time in Patent Office: 340 Days
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

The disclosure describes methods and compositions for reducing the duration of hyperglycemia and treating diabetes and complications thereof. A human subject with hyperglycemia is administered insulin, a water-based beverage, and a sodium salt formulation sufficient to accelerate said subject'"'"'s return to a non-hyperglycemic state. This process can be repeated multiple times within a given time period.

Claims

1. A method for reducing the duration of hyperglycemia which comprises the following steps:

A. testing the starting blood glucose level of a human subject to determine if the subject'"'"'s blood glucose level is hyperglycemic; and

B. if said testing indicates that said subject'"'"'s starting blood glucose level is hyperglycemic, administering to said subject both a dose of insulin and a sufficient dose of a sodium salt such that said subject'"'"'s blood glucose level drops to sub-hyperglycemic levels within 75 minutes of administering said sodium salt,

wherein said sodium salt is administered at a dose of sodium between 10 mg sodium per kg body weight of said subject and 100 mg sodium per kg body weight of said subject,

wherein said dose of said sodium salt is administered orally, and

wherein at least one sodium salt other than sodium chloride is administered at a dose of greater than 5 mg sodium per kg body weight of said subject.

2. The method of claim 1, wherein said human subject has diabetes.

3. The method of claim 2, wherein said human subject has Type 1 diabetes.

4. The method of claim 1, wherein said steps of testing said starting blood glucose level and administering said sufficient dose of a sodium salt are performed by said subject.

5. The method of claim 1, wherein said sufficient dose of a sodium salt is co-administered with at least 6 ounces of a beverage.

6. The method of claim 1, wherein said sufficient dose of a sodium salt is administered orally in a dosage form selected from the group consisting of a pill, a tablet, a lozenge, a bar, and a granular formulation.

7. The method of claim 1, wherein said sufficient dose of said sodium salt is provided in a packaged granular formulation which, upon addition to a drinkable water-based beverage, dissolves in said drinkable water-based beverage.

8. The method of claim 1, wherein said sodium salt that is administered at said sufficient dose is selected from the group consisting of sodium acetate, sodium citrate, sodium ascorbate, sodium bicarbonate, sodium carbonate, sodium gluconate, sodium lactate, sodium phosphate, sodium carboxymethyl cellulose and sodium tartrate, and combinations thereof.

9. The method of claim 1, wherein said sodium salt that is administered at said sufficient dose is selected from the group consisting of sodium acetate, sodium citrate, and combinations thereof.

10. The method of claim 1, wherein said sufficient dose of a sodium salt comprises at least two different sodium salts.

11. The method of claim 1, wherein said sufficient dose of a sodium salt does not comprise sodium chloride.

12. The method of claim 10, wherein one of said at least two different sodium salts is sodium chloride, wherein sodium chloride is administered to said subject at a dose greater than 5 mg sodium chloride per kg body weight of said subject and less than 100 mg sodium chloride per kg body weight of said subject, and wherein said sodium chloride comprises less than 50% by weight of the total dosage of sodium salts.

13. The method of claim 1, wherein said sufficient dose of a sodium salt is administered in the form of a foodstuff.

14. The method of claim 1, wherein said sequential steps of testing said starting blood glucose level and administering said sufficient dose of a sodium salt are performed at least three times within a three month period.

15. The method of claim 1, wherein said sufficient dose of a sodium salt is administered to the hyperglycemic human being multiple times within a year, three months, one month, a week, or even a day;

not more than ten times in a week;

or at least any of three, six, ten, 20, or 30 times within a three-month period.

16. The method of claim 1, wherein an antiemetic agent is co-administered with said sufficient dose of a sodium salt.

17. The method of claim 1, wherein a sufficient dose of a sodium salt is administered only if said subject'"'"'s starting blood glucose level is significantly hyperglycemic.

18. The method of claim 1, wherein a sufficient dose of a sodium salt is administered only if said subject'"'"'s starting blood glucose level is greater than 250 mg/dL.

19. The method of claim 1, wherein a sufficient dose of a sodium salt is administered only if said subject'"'"'s starting blood glucose level is greater than 300 mg/dL.

20. The method of claim 1, wherein said method reduces the likelihood of the subject requiring hospitalization for diabetic ketoacidosis.

21. The method of claim 1, wherein said sufficient dose of a sodium salt and said dose of insulin are both administered within a 15-minute time period.