Synergistic combinations and methods of use

Abstract

Provided herein are pharmaceutical compositions that are useful for the treatment of diabetes and associated conditions, diseases, and disorders.

What is claimed is: 
     
         1 . An ultra-low dose, anti-diabetic drug combination, consisting of:
 a) an ultra-low-dose, therapeutically-effective amount of a dipeptidyl peptidase IV (DPP IV) inhibitor, or a salt or hydrate thereof;   b) an ultra-low-dose, therapeutically-effective amount of a biguanide, or a salt or hydrate thereof;   c) an ultra-low-dose, therapeutically-effective amount of empagliflozin, or a salt or hydrate thereof; and   d) an excipient.   
     
     
         2 . The drug combination of  claim 1 , wherein the DPP IV inhibitor is sitagliptin, or a salt or hydrate thereof. 
     
     
         3 . The drug combination of  claim 2 , wherein the dose of sitagliptin is about 16.25 mg to about 18.75 mg. 
     
     
         4 . The drug combination of  claim 1 , wherein the biguanide is metformin, or a salt or hydrate thereof. 
     
     
         5 . The drug combination of  claim 4 , wherein the dose of metformin is about 325 mg to about 375 mg. 
     
     
         6 . The drug combination of  claim 1 , wherein the dose of empagliflozin is about 4.5 mg to about 7.5 mg. 
     
     
         7 . The drug combination of  claim 1 , wherein the DPP IV inhibitor is sitagliptin, or a salt or hydrate thereof and the biguanide is metformin, or a salt or hydrate thereof. 
     
     
         8 . The drug combination of  claim 7 , wherein the dose of sitagliptin is about 5.0 mg to about 18.75 mg, the dose of metformin is about 100 mg to about 375 mg, and the dose of empagliflozin is about 2.0 mg to about 7.5 mg. 
     
     
         9 . The drug combination of  claim 7 , wherein the dose of sitagliptin is about 16.25 mg to about 18.75 mg, the dose of metformin is about 325 mg to about 375 mg, and the dose of empagliflozin is about 4.5 mg to about 7.5 mg. 
     
     
         10 . The drug combination of  claim 1 , wherein the combination is a synergistic combination. 
     
     
         11 . The drug combination of  claim 1 , wherein the combination of a), b), and c) produces a synergistic effect. 
     
     
         12 . The drug combination of  claim 1 , wherein the combination does not comprise any further additional anti-hyperglycemic or anti-diabetic agents. 
     
     
         13 . The drug combination of  claim 2 , wherein the combination produces a larger decrease in 2 hour post-prandial glucose as compared to a maximum decrease in the post-prandial glucose obtained about 100 mg of sitagliptin. 
     
     
         14 . The drug combination of  claim 4 , wherein the combination produces a larger decrease in 2 hour post-prandial glucose as compared to a maximum decrease in the post-prandial glucose obtained about 850 mg of metformin. 
     
     
         15 . The drug combination of  claim 4 , wherein the combination produces a larger decrease in 2 hour post-prandial glucose as compared to a maximum decrease in the post-prandial glucose obtained about 1700 mg of metformin.