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(12) Patent Application Publication (10) Pub. No.: US 2015/0174209 A1 Chiquette Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2015/0174209 A1 Chiquette Et Al US 2015O174209A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0174209 A1 Chiquette et al. (43) Pub. Date: Jun. 25, 2015 (54) INSULIN-PRAMLINTIDE COMPOSITIONS Publication Classification AND METHODS FOR MAKING AND USING THEMI (51) Int. Cl. A638/28 (2006.01) A619/00 (2006.01) (71) Applicants: AMYLIN PHARMACEUTICALS. G06F 9/00 (2006.01) LLC, San Diego, CA (US); UVA A6M 5/14 (2006.01) PATENT FOUNDATION Ab/a THE A61M 57315 (2006.01) UVALICENSING AND VENTURES A638/22 (2006.01) GROUP, Charlottesville, VA (US); 469/19 (2006.01) GRUPPO BIOMED MOD, Padova (IT) (52) U.S. Cl. CPC ................. A61 K38/28 (2013.01); A61K 38/22 (72) Inventors: Elaine Chiquette, San Antonio, TX (2013.01); A61 K9/0019 (2013.01); A61 K9/19 (US); Kathrin Herrmann, San Diego, (2013.01); A61M 5/1407 (2013.01); A61M CA (US); David G. Maggs, San Diego, 5/31596 (2013.01); G06F 19/3468 (2013.01) CA (US); Orville G. Kolterman, Poway, (57) ABSTRACT CA (US); Jui-Chen Lin, San Diego, CA In alternative embodiments, the invention provides formula (US); Steven Shijun Ren, San Diego, tions, pharmaceutical compositions, devices and other prod CA (US); Li Jin, San Diego, CA (US); ucts of manufacture comprising a therapeutically effective Claudio Cobelli, Padova (IT): Boris mixture of an insulin and a pramlintide, and methods for Kovatchev, Charlottesville, VA (US) making and using them. For example, methods and compo sitions of the invention are used in the treatment or amelio (73) Assignees: AMYLIN PHARMACEUTICALS. ration of a diabetes, a dementia or Alzheimer's disease, any LLC, San Diego, CA (US); UVA abnormality of blood glucose control, an inability to control PATENT FOUNDATION Ab/a THE blood glucose, an elevation of fasting glucose or Impaired UVALICENSING AND VENTURES Fasting Glucose (IFG), an abnormality of tolerance to a glu cose load or Impaired Glucose Tolerance (IGT), a hypergly GROUP, Charlottesville, VA (US); cemia induced by an illness, a trauma, a medication admin GRUPPO BIOMED MOD, Padova, PA istration or a form of metabolic, psychological or physical (IT) stress, or a hyperglycemia induced by Steroids (steroid-in duced diabetes), a latent autoimmune diabetes in adults (21) Appl. No.: 14/403,177 (LADA), a postprandial or reactive Hypoglycemia oran insu lin resistance, a PolyCystic Ovary Syndrome (PCOS), a (22) PCT Fled: May 24, 2013 ketoacidosis, a gestational diabetes, a hyperkalemia, a cancer or cachexia, a beta blocker overdose, or a jaundice. In alter (86). PCT No.: PCT/US2O13/042745 native embodiments, the invention provides insulin pumps, S371 (c)(1), devices, Subcutaneous insulin infusion therapy devices, con (2) Date: Nov. 22, 2014 tinuous Subcutaneous insulin infusion therapy devices, infu sion therapy devices, reservoirs, ampoules, vials, Syringes, cartridges, disposable pen or jet injectors, prefilled pens or Related U.S. Application Data Syringes or cartridges, cartridge or disposable pen orjet injec tors, two chambered or multi-chambered pumps, Syringes, (60) Provisional application No. 61/651,945, filed on May cartridges or pens or jet injectors, or an artificial pancreas, 25, 2012, provisional application No. 61/773,737, comprising a formulation having an insulin pramlintide ratio filed on Mar. 6, 2013. of the invention. at Charlier Syrige anci Casticigs. 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