METHOD FOR TREATING HYPERGLYCEMIA WITH GLP-1
A method for treating hyperglycemia and/or diabetes in a subject is provided. In particular, the method is directed for the treatment of patients with type 2 diabetes mellitus who have a fasting blood glucose concentration greater than about 8 mM, wherein the patient is administered a formulation comprising a GLP-1 molecule and a diketopiperazine by pulmonary inhalation with a dry powder inhalation system.
1 . An inhalable dry powder pharmaceutical composition comprising a therapeutically effective amount of an active agent and a diketopiperazine microparticle less than 10 μm in diameter;
wherein said active agent comprises at least one of a vasoactive agent, a neuroactive agent, a hormone, an anticoagulant, an immunomodulating agent, a cytotoxic agent, an antibiotic, an antiviral agent, an antigen, or an antibody; and
wherein said diketopiperazine comprises 3,6-di(N-X-4-aminobutyl)-2,5-diketopiperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl; or a pharmaceutically acceptable salt thereof.
2 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises at least one of insulin and analogs thereof, growth hormone, parathyroid hormone (PTH), ghrelin, granulocyte macrophage colony stimulating factor (GM-CSF), glucagon-like peptide 1 (GLP-1), Texas Red, alkynes, cyclosporins, clopidogrel and PPACK (D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone), antibodies and fragments thereof, cytokines, infectious agents, inflammatory mediators, hormones, and cell surface antigens.
3 . The dry powder pharmaceutical composition of claim 1 , wherein X is fumaryl.
4 . The dry powder pharmaceutical composition of claim 1 , wherein from about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm
5 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises a vasoactive agent.
6 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises a neuroactive agent.
7 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises a hormone.
8 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises an immunomodulating agent.
9 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises a cytotoxic agent.
10 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises an antibiotic.
11 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises an antiviral agent.
12 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises an antigen.
13 . The dry powder pharmaceutical composition of claim 1 , wherein said active agent comprises an antibody.