Method for treating post-prandial hypoglycemia

Inventors

Wilkison, William • Cheatham, Bentley • Green, James T.

Assignees

Kissei Pharmaceutical Co Ltd • Vogenx Inc

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Publication Number

US-11596644-B2

Patent

Publication Date

2023-03-07

Expiration Date


Abstract

Disclosed herein are methods, sodium-dependent glucose transporter (SGLT)1 compounds and compositions for the treatment of postprandial hypoglycemia, postprandial hypoglycemia that occurs as a consequence of gastric surgery.

Core Innovation

The disclosed invention relates to a method of treating a subject with post-prandial hypoglycemia associated with gastric surgery. The method comprises orally administering a sodium-dependent glucose transporter (SGLT)1 inhibitor compound of Formula I or Formula II, or a pharmaceutically acceptable salt thereof, to said subject. The compound inhibits SGLT1 in the intestinal lumen of the subject.

The invention defines an extensive structural scope for the SGLT1 inhibitor compounds of Formula I and Formula II by specifying substituent and ring variables. Formula I includes definitions of R1, R2, QA and TA, R3, R5, and R6, as well as X, Y, and Z, with multiple allowed ring and substituent classes for aryl and heteroaryl groups and various optional substitution patterns. Formula II similarly specifies variables including R7, R8, R9, n, p, R10, and related substituent sets.

The disclosure further identifies specific exemplary SGLT1 inhibitors and salt forms, including mizagliflozin and mizagliflozin salts, and describes additional therapeutic options such as combination therapy with alpha-glucosidase inhibitors or a GLP-1 receptor antagonist. The document also describes treatment effects on post-prandial glucose and insulin responses in examples.

Claims Coverage

The document includes one independent claim covering the overall method of treating post-prandial hypoglycemia associated with gastric surgery by oral administration of an SGLT1 inhibitor compound of Formula I or Formula II. The inventive features comprise the treatment setting, the oral dosing form and compound class, the structural formula scope, and the intestinal-lumen SGLT1 inhibition property.

Oral SGLT1 inhibition for gastric-surgery-associated PPH treatment

A method of treating a subject with post-prandial hypoglycemia associated with a gastric surgery, comprising orally administering a sodium-dependent glucose transporter (SGLT)1 inhibitor compound of Formula I or Formula II, or a pharmaceutically acceptable salt thereof, wherein the SGLT1 inhibitor compound inhibits SGLT1 in the intestinal lumen of the subject.

Across the independent claim, the core inventive coverage is a treatment method for gastric-surgery-associated post-prandial hypoglycemia that relies on oral administration of an SGLT1 inhibitor of Formula I or Formula II (or a pharmaceutically acceptable salt) acting by inhibiting SGLT1 in the intestinal lumen.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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