Combination therapy of GPR119 agonists and DPP-4 inhibitors
The present invention relates to combinations of GPR119 receptor agonists with DPP-4 inhibitors and their use thereof for treating or preventing cardiovascular and metabolic disorders, including diabetes mellitus, non-alcoholic fatty liver disease (NAFLD), NAFL, NASH, dyslipidemia, and related disorders thereto.
1 . A pharmaceutical combination comprising:
(a) a GPR119 agonist of Formula IA:
tautomers thereof, stereoisomers thereof, and pharmaceutically acceptable salts thereof in a range from 0.001 mg to 1000 mg; and
(b) sitagliptin or a pharmaceutically acceptable salt thereof in a range from 25 mg to 200 mg.
2 . The pharmaceutical combination as claimed in claim 1 , wherein the combination further comprises at least one pharmaceutically acceptable carrier.
3 . The pharmaceutical combination as claimed in claim 1 , wherein the GPR119 agonist and sitagliptin are present in a single dosage form.
4 . The pharmaceutical combination as claimed in claim 1 , wherein the GPR119 agonist and sitagliptin are present each in a separate dosage form.
5 . The pharmaceutical combination as claimed in claim 1 , wherein the GPR119 agonist and sitagliptin are administered simultaneously, sequentially or alternately.
6 . The pharmaceutical combination as claimed in claim 1 , wherein the pharmaceutical combination is in an oral dosage form.
7 . A kit comprising:
(a) a first component comprising a GPR119 agonist of Formula IA:
tautomers thereof, stereoisomers thereof, and pharmaceutically acceptable salts thereof in a range from 0.001 mg to 1000 mg;
(b) a second component comprising sitagliptin or a pharmaceutically acceptable salt thereof in a range from 25 mg to 200 mg, and
(c) optionally one or more pharmaceutically acceptable carriers.