Salts or co-crystals of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid and uses thereof

A method of treating type 1 diabetes or type 2 in a human in need thereof comprising orally administering to the human with type 1 diabetes or type 2 diabetes a solid dosage form comprising a crystalline form of the sodium salt, piperazine salt, or hydrochloride salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid, in combination with insulin therapy, wherein the insulin therapy comprises continuous subcutaneous insulin infusion or multiple daily subcutaneous injections of insulin;

• wherein:
• (a) the sodium salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an X-ray powder diffraction (XRPD) pattern with peaks at the following diffraction angles 4.4±0.2, 9.4±0.2, and 20.0±0.2 degrees two theta as measured using Cu, Kα radiation (Form A);
• (b) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern comprising peaks at the following diffraction angles 4.9±0.2, 12.5±0.2, and 14.9±0.2 degrees two theta as measured using Cu, Kα radiation (Form B);
• (c) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern comprising peaks at the following diffraction angles 5.1±0.2, 13.6±0.2, and 20.5±0.2 degrees two theta as measured using Cu, Kα radiation (Form C) of Formula (I);
• (d) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern comprising peaks at the following diffraction angles 5.5±0.2, 16.7±0.2, and 19.9±0.2 degrees two theta as measured using Cu, Kα radiation (Form D) of Formula (I);
• (e) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern comprising peaks at the following diffraction angles 4.9±0.2, 12.5±0.2, and 18.3±0.2 degrees two theta as measured using Cu, Kα radiation (Form E);
• or
• (f) the hydrochloride salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern comprising peaks at the following diffraction angles 4.6±0.2, 7.2°±0.2, and 17.7°±0.2 degrees two theta as measured using Cu, Kα radiation (Form F).

A method of treating type 1 diabetes or type 2 in a human in need thereof comprising orally administering to the human with type 1 diabetes or type 2 diabetes a solid dosage form comprising a crystalline form of the sodium salt, piperazine salt, or hydrochloride salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid, in combination with insulin therapy, wherein the insulin therapy comprises continuous subcutaneous, wherein:

• (a) the sodium salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an X-ray powder diffraction (XRPD) pattern substantially the same as shown in FIG. 1 as measured using Cu, Kα radiation (Form A);
• (b) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern substantially the same as shown in FIG. 5 as measured using Cu, Kα radiation (Form B);
• (c) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern substantially the same as shown in FIG. 9 as measured using Cu, Kα radiation (Form C) of Formula (I);
• (d) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern substantially the same as shown in FIG. 12 as measured using Cu, Kα radiation (Form D) of Formula (I);
• (e) the piperazine salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern substantially the same as shown in FIG. 13 as measured using Cu, Kα radiation (Form E);
• or
• (f) the hydrochloride salt of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid salt is characterized as having an XRPD pattern substantially the same as shown in FIG. 16 as measured using Cu, Kα radiation (Form F).