METHODS, COMPOUNDS, AND COMPOSITIONS FOR TREATING METABOLIC DISORDERS AND DIABETES
Disclosed herein are methods, compounds and compositions for preventing or treating a pancreatic disorder, including diabetes mellitus (e.g. type 1 and/or type 2 diabetes). The invention generally includes administering to a subject 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof, e.g., 1,3-propanedisulfonic acid sodium salt. The invention also relates to methods, compounds and compositions for improving or at least stabilizing pancreatic function(s) and for the prevention and/or treatment of metabolic syndrome and its components. The invention further relates to methods, compounds and compositions for the prevention and/or treatment of dyslipidemia, and more particularly for reducing levels of harmful serum lipid levels, especially cholesterol and triglycerides in patients in need thereof, including diabetic patients.
1 . A method for preventing or treating a pancreatic disorder in a subject in need thereof, comprising administering to said subject an effective amount of a compound of the Formula (I):
Y—(CH 2 ) n —(CH) t —[CH 2 Y] m (I)
wherein Y is SO 3 X or OSO 3 X independently chosen for each occurrence; X is a cationic group which independently for each occurrence is hydrogen, lithium, sodium, potassium, calcium, magnesium, trialkylammonium or aluminum; n is 1, 2, 3 or 4; t is 0 when m is 1; and t is 1 when m is 2.
2 . The method of claim 1 , wherein the subject has hyperglycemia.
3 . The method of claim 1 , wherein the pancreatic disorder is diabetes mellitus.
4 . The method of claim 3 , wherein said diabetes is associated with features of metabolic syndrome.
5 . The method of claim 1 , wherein said method further comprises administering a second agent.
6 . The method of claim 5 , wherein said second agent is a biguanide or a sulfonylurea.
7 . The method of claim 6 , wherein said second agent is metformin.
8 . The method of claim 7 , wherein the method further comprises administering a sulfonylurea.
9 . A method for preventing or treating metabolic syndrome in a subject in need thereof, comprising administering to said subject an effective amount of a compound of the Formula (I):
Y—(CH 2 ) n —(CH) t —[CH 2 Y] m (I)
wherein Y is SO 3 X or OSO 3 X independently chosen for each occurrence; X is a cationic group which independently for each occurrence is hydrogen, lithium, sodium, potassium, calcium, magnesium, trialkylammonium or aluminum; n is 1, 2, 3 or 4; t is 0 when m is 1; and t is 1 when m is 2.
10 . A method for preventing or treating diabetes mellitus in a subject in need thereof, comprising administering to said subject an effective amount of a compound of the Formula (I):
Y—(CH 2 ) n —(CH) t —[CH 2 Y] m (I)
wherein Y is SO 3 X or OSO 3 X independently chosen for each occurrence; X is a cationic group which independently for each occurrence is hydrogen, lithium, sodium, potassium, calcium, magnesium, trialkylammonium or aluminum; n is 1, 2, 3 or 4; t is 0 when m is 1; and t is 1 when m is 2.
11 . The method of claim 10 , wherein the diabetes mellitus is type 1 diabetes.
12 . The method of claim 11 , wherein the diabetes mellitus is type 2 diabetes.
13 . The method of claim 10 , wherein said diabetes is associated with features of metabolic syndrome.
14 . The method of claim 10 , wherein said method positively affects in said subject at least one pancreatic function parameter which is size, growth and/or secreting activity of islets of Langerhans, size, growth and/or secreting activity of beta-cells; insulin secretion, insulin blood levels, or glucose blood levels.
15 . The method of claim 1 , wherein said method restores or improves pancreatic function by preventing loss or stimulating neogenesis of islets of Langerhans.
16 . The method of claim 14 , wherein said pancreatic function is assessed by measuring serum insulin levels, by measuring glycemia, by measuring diuresis, by measuring kalemia, by imaging of the pancreas or by making a histological examination of the pancreas.
17 . The method of claim 1 , wherein said compound is 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof.
18 . The method of claim 1 , wherein said compound is 1,3-propanedisulfonic acid disodium salt.
19 . The method of claim 1 , wherein the subject does not have amyloidosis.
20 . The method of claim 1 , wherein the subject does not have AA-amyloidosis.
21 . The method of claim 1 , wherein the subject does not have IAPP-amyloidosis.
22 . The method of claim 1 , wherein the subject does not have a renal disorder.
23 . The method of claim 1 , wherein the subject does not have a nephropathy (e.g. diabetic nephropathy).
24 . Use of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof for the prevention or treatment of a pancreatic disorder in a subject in need thereof.
25 . Use of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof for the prevention or treatment of the metabolic syndrome in a subject in need thereof.
26 . Use of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof for the prevention or treatment of diabetes mellitus in a subject in need thereof.
27 . Use of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof for the prevention or treatment of diabetes mellitus with features of metabolic syndrome in a subject in need thereof.
28 . A method of preventing or decreasing proteinuria in a subject in need thereof, comprising administering to said subject an effective amount of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof.
29 . A method of increasing insulin secretion and/or increasing insulin sensitivity in a subject in need thereof, comprising administering to said subject an effective amount of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof.
30 . A method of decreasing insulin resistance in a subject in need thereof, comprising administering to said subject an effective amount of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof.
31 . A method of decreasing hyperglycemia in a subject in need thereof, comprising administering to said subject an effective amount of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof.
32 . A method for delaying the requirement for treating a diabetic patient with insulin by administering an effective amount of 1,3-propanedisulfonic acid.