Synergistic compositions
The present invention describes a synergistic composition comprising of one or more statins, or one or more dipeptidyl peptidase IV (DPP IV) inhibitor or one or more biguanide antihyperglycaemic agent and a PPAR agonist of formula (Ia) for the treatment of diabetes, especially non-insulin dependent diabetes (NIDDM) or Type 2 diabetes and conditions associated with diabetes mellitus and to compositions suitable for use in such method. The invention also describes the preparation of such compositions. The present invention also relates to certain novel salts of the PPAR agonist of formula (I), processes for the preparation of these novel salts and use thereof.
1. Synergistic composition comprising a compound of formula (Ia)
wherein ‘M + ’ represents Calcium, Magnesium, Sodium, Potassium, Zinc and Lithium and one or more therapeutic agent selected from one or more DPP IV inhibitors, one or more biguanide antihyperglycaemic agents, one or more statins, one or more thiazolidinediones, one or more sulfonylureas, one or more SGLT2 inhibitors, one or more insulin sensitizers or one or more GLP-1 agonists.
2. The synergistic composition as claimed in claim 1 , wherein the one or more DPP IV inhibitors are selected from Sitagliptin, Vildagliptin, Saxagliptin, Alogliptin and Linagliptin.
3. The synergistic composition as claimed in claim 1 , wherein the one or more statins are selected from Lovastatin, Pravastatin, Fluvastatin, Simvastatin, Atorvastatin, Rosuvastatin and Pitavastatin.
4. The synergistic composition as claimed in claim 1 , wherein the one or more biguanide antihyperglycaemic agents are selected from Metformin, Buformin or Phenformin.
5. The synergistic composition as claimed in claim 1 , wherein the one or more thiazolidinediones are selected from Pioglitazone and Rosiglitazone.
6. The synergistic composition as claimed in claim 1 , wherein the one or more sulphonylureas are selected from glibenclamide, glipizide, gliclazide, glimepiride, tolazamide, tolbutamide, acetohexamide, carbutamide, chlorpropamide, glibomuride, gliquidone, glisentide, glisolamide, glisoxepide, glyclopyamide, glycylamide and glipentide.
7. The synergistic composition as claimed in claim 1 , wherein the one or more SGLT2 inhibitors are selected from Dapagliflozin, Canagliflozin, Empagliflozin, Ertugliflozin and Ipragliflozin.
8. The synergistic composition as claimed in claim 1 , wherein the one or more GLP-1 agonists are selected from Exenatide, Liraglutide and Dulaglutide.
9. A method for the treatment of dyslipidemia, hypertriglyceridemia or diabetes mellitus which comprises administering an effective, non-toxic and pharmaceutically acceptable amount of a composition according to claim 1 , to a mammal in need thereof.
10. A composition according to claim 1 , further comprising another suitable therapeutic agent for the treatment of obesity, diabetes mellitus, especially Type 2 diabetes and conditions associated with diabetes mellitus.
11. The composition as claimed in claim 10 , wherein the another suitable therapeutic agent is selected from an antidiabetic agent, an alpha glucosidase inhibitor, a biguanide, an insulin secretagogue or an insulin sensitizer and sulphonylureas.
12. The composition according to claim 1 , further comprising one or more pharmaceutically acceptable excipients.
13. The pharmaceutical composition as claimed in claim 12 in the form of a tablet, capsule, powder, granule, lozenge, suppository, reconstitutable powder, or liquid preparation.
14. The composition as claimed in claim 12 , wherein the pharmaceutically acceptable excipient is selected from suitable binding agents, fillers, lubricants, glidants, disintegrants and wetting agents.