Combination therapy for the treatment of diabetes

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 R 1a is a halogen atom, a lower alkyl group, or a lower alkoxy group, and R 2a and R 3a are hydrogen atoms;

and Ring B is

wherein R 4a 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 —CH 2 —,

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.