# US 10,500,186 B2 · SGLT-2 inhibitors for treating metabolic disorders in patients with renal impairment or chronic kidney disease

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- Number: US 10,500,186 B2
- Document ID: US10500186B2
- Status: Granted
- Kind: B2
- Application number: 16/244,161
- Filed: 2019-01-10
- Published: 2019-05-16
- Granted: 2019-12-10
- Earliest claimed: 2014-11-10
- Assignees: Merck Sharp & Dohme Corp.; Pfizer Inc.
- Applicants: Merck Sharp & Dohme Corp.; Pfizer Inc.
- Inventors: Ramachandra G. Naik; Elizabeth S. Ommen; James Michael Rusnak; Steven G. Terra
- Web page: https://patentgrep.com/patent/US10500186B2

## CPC

- A61K 31/357: having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/35: having six-membered rings with one oxygen as the only ring hetero atom
- A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to certain SGLT-2 inhibitors, such as ertugliflozin or a co-crystal or a pharmaceutically acceptable salt thereof, for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD). The present invention also relates to methods for preventing neuronal damage following the incidence of ischemic stroke and close-head traumatic brain injury in animals comprising the step of administering to an animal, in need of such treatment, a therapeutically effective amount of ertugliflozin or a co-crystal or a pharmaceutically acceptable salt thereof.

## Claims

### Claim 1

A method of treating prediabetes, type 1 or type 2 diabetes comprising: a) determining the estimated glomerular filtration rate (eGFR) of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes; b) administering ertugliflozin or a co-crystal or a pharmaceutically acceptable salt thereof to the patient, if the eGFR of the patient is between ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2.

### Claim 2 (depends on 1)

The method of claim 1, wherein ertugliflozin or a co-crystal or a pharmaceutically acceptable salt thereof is administered if the eGFR of the patient is between ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2.

### Claim 3

A method of treating prediabetes, type 1 or type 2 diabetes mellitus comprising: a) determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2; b) administering ertugliflozin or a co-crystal or a pharmaceutically acceptable salt thereof to the patient.

### Claim 4 (depends on 3)

The method of claim 3 comprising determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2.