Claims for Patent: 11,576,894

Summary for Patent: 11,576,894

Title:	Combination therapy for the treatment of diabetes
Abstract:	The present invention is directed to co-therapy and methods for the treatment and prevention of glucose-related disorders such as Type 2 diabetes mellitus and Syndrome X. The present invention is further directed to pharmaceutical compositions for the co-therapy and methods described herein.
Inventor(s):	Yin Liang, John Ryan, Abraham B. Woldu, Lisa Wu
Assignee:	Janssen Pharmaceutica NV
Application Number:	US15/413,480
Patent Claims:	1. A pharmaceutical composition comprising (a) metformin or a pharmaceutically acceptable salt thereof in an amount in the range of from about 500 mg to about 2000 mg; and (b) a compound of formula (I) wherein Ring A is wherein R1a is a halogen atom, a lower alkyl group, or a lower alkoxy group, and R2a and R3a are hydrogen atoms; and Ring B is wherein R4a is a phenyl group optionally substituted by a substituent selected from the group consisting of a halogen atom, a cyano group, a lower alkyl group, a halo-lower alkyl group, a lower alkoxy group, a halo-lower alkoxy group, a mono- or di-lower alkylamino group, a carbamoyl group, and a mono- or di-lower alkylcarbamoyl group; or a heterocyclyl group optionally substituted by a halogen atom, a cyano group, a lower alkyl group, a lower alkoxy group, a carbamoyl group, or a mono- or di-lower alkylcarbamoyl group, and Rya is a hydrogen atom; and Y is —CH2—, or a pharmaceutically acceptable salt thereof; in an amount of from about 10 mg to about 300 mg; and between about 5% and about 50% by weight of diluent which is microcrystalline cellulose; between about 1% and about 10% by weight of binder comprising a material selected from the group consisting of polyvinylpyrrolidone, methylcellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose; and between about 1% and about 10% by weight of disintegrant which is croscarmellose sodium. 2. The pharmaceutical composition as in claim 1, wherein the metformin or pharmaceutically acceptable salt thereof is metformin hydrochloride. 3. A pharmaceutical composition comprising (a) metformin hydrochloride in an amount in the range of from about 100 mg to about 2000 mg; (b) a compound of formula (I-X) or a pharmaceutically acceptable salt thereof in an amount in the range of from about 50 mg to about 500 mg; and (c) between about 5% and about 50% by weight of diluent which is microcrystalline cellulose; (d) between about 1% and about 10% by weight of binder comprising a material selected from the group consisting of polyvinylpyrrolidone, methylcellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose, and (e) between about 1% and about 10% by weight of disintegrant which is croscarmellose sodium. 4. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 250 mg, about 500 mg, about 750 mg, about 850 mg, or about 1000 mg; and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 50 mg, about 100 mg, about 150 mg or about 300 mg. 5. The pharmaceutical composition as in claim 3, wherein the compound of formula (I-X) is a crystalline hemihydrate. 6. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 500 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 50 mg. 7. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 1000 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 50 mg. 8. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 500 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 150 mg. 9. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 1000 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 150 mg. 10. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 850 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 50 mg. 11. The pharmaceutical composition as in claim 3, wherein the metformin hydrochloride is present in an amount of about 850 mg and wherein the compound of formula (I-X) or pharmaceutically acceptable salt thereof is present in an amount of about 50 mg. 12. The pharmaceutical composition as in claim 3, further comprising between about 0.1% and about 2% by weight of a lubricant.