Treatment of diabetes mellitus

Abstract

The present disclosure provides methods and compositions for treating patients with diabetes mellitus and / or obesity.

Description

Abstract This disclosure provides methods and compositions for treating patients with diabetes and / or obesity.

Claims

CLAIMS 1. A method of treating type 1 diabetes mellitus (T1DM) in a patient in need thereof, comprising administering by subcutaneous injection to the patient in need thereof a compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof:(Formula VII) (SEQ ID NO:1), wherein the compound is administered at a body weight-independent dose of 1 mg to 20 mg.

2. A method of treating type 2 diabetes mellitus (T2DM) in a patient in need thereof, comprising administering by subcutaneous injection to the patient in need thereof a compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof:(Formula VII) (SEQ ID NO:1), wherein the compound is administered at a body weight-independent dose of 1 mg to 20 mg.

3. The method of claim 1 or 2, where the method is used to improve glycemic control in the patient, increase insulin sensitivity in the patient, increase insulin-independent glucose disposal in the patient,reduce the need for therapeutic insulin in the patient, alleviate hypertension in the patient, and / or reduce atherogenic lipids in the patient.

4. The method of any one of claims 1-3, wherein the patient is overweight or obese, and the method reduces body weight of the patient.

5. A method of weight management in a patient in need thereof, comprising administering by subcutaneous injection to the patient in need thereof a compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof:(Formula VII) (SEQ ID NO:1), wherein the compound is administered at a body weight-independent dose of 1 mg to 20 mg.

6. The method of claim 5, wherein the patient has type 1 or type 2 diabetes mellitus.

7. The method of any one of claims 1-6, wherein the administration of the compound is an adjunct to one or more additional therapies.

8. The method of claim 7, wherein the one or more additional therapies comprise insulin therapy, diet therapy, exercise therapy, hypertension therapy, and / or blood lipid-lowering therapy.

9. The method of any one of claims 1-8, wherein the administering step is repeated at an interval of one to seven days.

10. The method of any one of claims 1-8, wherein the administering step is repeated once daily.

11. The method of any one of the preceding claims, wherein the compound is administered at a dose that agonizes both GLP-1 receptor and GIP receptor.

12. The method of any one of the preceding claims, wherein the dose is about 1.5, 1.8, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mg.

13. The method of any one of the preceding claims, wherein the dose is 1.77, 3.25 mg, or 4 mg.

14. The method of any one of the preceding claims, wherein the dose is 1.1, 1.8, 2.6, 3.3, 4.1, 5.2, or 6.6 mg.

15. The method of any one of the preceding claims, wherein the patient has a BMI of 25 kg / m2or higher.

16. The method of any one of the preceding claims, wherein the compound is administered to the patient in a pharmaceutical composition comprising: the compound at a concentration of 15 mg / mL, di-sodium hydrogen phosphate heptahydrate / sodium dihydrogen phosphate monobasic buffer solution, optionally at a concentration of 20 mM, propylene glycol, and phenol, further optionally wherein the pharmaceutical composition is at pH 7.

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17. A pharmaceutical composition comprising (i) a compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof, at a concentration of 15 mg / mL:(Formula VII) (SEQ ID NO:1), (ii) di-sodium hydrogen phosphate heptahydrate / sodium dihydrogen phosphate monobasic buffer solution, optionally at a concentration of 20 mM, (iii) propylene glycol, and (iv) phenol, further optionally wherein the pharmaceutical composition is at pH 7.

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18. A compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof, or a pharmaceutical composition of claim 17, for use in the method of any one of claims 1-16:(Formula VII) (SEQ ID NO:1).

19. Use of a compound comprising the following structure or a pharmaceutically acceptable salt or ester thereof, or a pharmaceutical composition of claim 17, for the manufacture of a medicament for use in the method of any one of claims 1-16:(Formula VII) (SEQ ID NO:1).

20. An article of manufacture for use in the method of any one of claims 1-16, wherein the article of manufacture comprises one or more units of said dose, optionally a single dose unit.

21. An article of manufacture for use in the method of any one of claims 1-16, wherein the article of manufacture comprises five units of said dose.

22. The article of manufacture for use of claim 20 or 21, wherein the article of manufacture is a syringe, injection pen, or an injector, optionally wherein the article of manufacture is single-use.

23. The article of manufacture for use of any one of claims 20-22, wherein the article of manufacture comprises a needle-based injection system with an integrated non-replaceable 3- mL Type 1 glass cartridge and a pharmaceutical composition comprising 3 mL of the agonist at a concentration of 15 mg / mL.