Pharmaceutical composition comprising a glp-1-agonist and methionine

Abstract

A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivates where appropriate.

1 . An aqueous liquid composition consisting essentially of:
 (a) desPro 36 exendin-4(1-39)-Lys 6 -NH2 (“AVE0010”) or a pharmacologically tolerable salt thereof at a concentration of about 0.025 mg/mL to about 0.1 mg/mL;   (b) insulin glargine or a pharmacologically tolerable salt thereof at a concentration of about 3.64 mg/mL;   (c) L-methionine;   (d) m-cresol;   (e) 85% glycerol;   (f) zinc chloride, and   (g) water in a quantity sufficient for the volume of the composition to total about 1 mL.   
     
     
         2 . The aqueous liquid composition of  claim 1 , wherein the composition consists essentially of:
 (c) about 3 mg L-methionine;   (d) about 2.7 mg m-cresol;   (e) about 20 mg 85% glycerol; and   (f) about 0.06 mg zinc chloride.   
     
     
         3 . The aqueous liquid composition of  claim 1 , wherein the composition further consists essentially of hydrochloric acid and sodium hydroxide such that the composition has a pH in the range of 3.5 to 4.5.