PHARMACEUTICAL COMPOSITION COMPRISING A GLP-1-AGONIST AND METHIONINE
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.