USE OF LOW DOSE GLUCAGON
The present invention provides methods for controlling or reducing caloric intake in a subject by administering a low dose of a stable glucagon formulation. The present invention further provides methods for treating mild or moderate hypoglycemia in a subject in need thereof subject by administering a low dose of a stable glucagon formulation. Kits for practicing the methods of the invention are also provided.
1 . A method for controlling or reducing body weight in a subject in need thereof, the method comprising: administering to the subject a low dose of a stable glucagon formulation in response to a hunger cue in the subject, wherein the glucagon formulation is stable for at least one week at controlled room temperature; thereby controlling or reducing body weight in the subject.
2 . The method of claim 1 , wherein the subject is diabetic.
3 . The method of claim 1 , wherein the subject is normoglycemic.
4 . The method of claim 1 , wherein the subject is a human adult.
5 . The method of claim 4 , wherein the glucagon formulation is administered to the subject at a dose of about 50 μg to about 200 μg.
6 . The method of claim 5 , wherein the glucagon formulation is administered to the subject at a dose of about 150 μg.
7 . The method of claim 1 , wherein the subject is a human child.
8 . The method of claim 7 , wherein the glucagon formulation is administered to the subject at a dose of about 5 μg to about 150 μg.
9 . The method of claim 1 , wherein the glucagon formulation is stable for at least one month at controlled room temperature.
10 . The method of claim 1 , wherein the glucagon formulation is reconstituted with a pharmaceutically acceptable carrier
11 . The method of claim 1 , wherein the glucagon formulation comprises an ionization stabilizing excipient, wherein (i) the glucagon, glucagon analogue, or salt thereof is dissolved in the aprotic solvent in an amount from about 0.1 mg/mL up to the solubility limit of the glucagon, glucagon analogue, or salt thereof, and (ii) the ionization stabilizing excipient is dissolved in the aprotic solvent in an amount to stabilize the ionization of the glucagon peptide or salt thereof.
12 . The method of claim 11 , wherein the ionization stabilizing excipient is at a concentration of 0.1 mM to less than 100 mM.
13 . The method of claim 11 , wherein the ionization stabilizing excipient is a mineral acid.
14 . The method of claim 13 , wherein the mineral acid is hydrochloric acid.
15 . The method of claim 11 , wherein the aprotic solvent is DMSO.
16 . The method of claim 11 , wherein the aprotic solvent is a deoxygenated aprotic solvent.
17 . The method of claim 11 , wherein the ionization stabilizing excipient is HCl and the aprotic solvent is DMSO.
18 . The method of claim 11 , wherein the composition has a moisture content of less than 10, 5, or 3%.
19 . The method of claim 11 , wherein the composition further comprises a preservative at less than 10, 5, or 3% w/v.
20 . The method of claim 19 , wherein the preservative is benzyl alcohol.
21 . The method of claim 11 , wherein the composition further comprises a sugar alcohol at less than 10, 5, or 3% w/v.
22 . The method of claim 21 , wherein the sugar alcohol is mannitol.
23 .- 158 . (canceled)