Insulin analogs having protracted time action

• US 20060217290A1
• Filed: 04/22/2004
• Published: 09/28/2006
• Est. Priority Date: 04/29/2003
• Status: Abandoned Application

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Dimarchi, Richard Dennis, Zhang, Lianshan, Kohn, Wayne David
• Application Number:
  US10/553,163
• Publication Number:
  US 20060217290A1
• Time in Patent Office: Days
• US Class Current: 514/6.200
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: C07K 14/62 Insulins

Abstract

The present invention provides the insulin analog A0^Arg A21^Gly B31^Arg B32^Arg, which provides a protracted, even basal duration of action. The present invention also provides a method of treating diabetes mellitus comprising administering the insulin analog.

Claims

1. A pharmaceutical composition comprising an acidic aqueous solution comprising the insulin analog A0^ArgA21^GlyB31^ArgB32^Arg-human insulin, wherein the insulin analog is not covalently bound to a fatty acid.

4. The pharmaceutical composition of claim 1, further comprising one or more pharmaceutically acceptable excipients.

5. The pharmaceutical composition of claim 1, further comprising a divalent metal cation.

6. The pharmaceutical composition of claim 5, wherein the divalent metal cation is zinc.

7. The pharmaceutical composition of claim 1, further comprising a phenolic preservative.

8. The pharmaceutical composition of claim 1, further comprising an isotonicity agent.

9. A method of treating hyperglycemia, the method comprising administering the pharmaceutical composition of claim 1 to a subject in an amount sufficient to regulate blood glucose concentration in the subject.

10. A method of treating hyperglycemia, the method comprising administering the pharmaceutical composition of any one of claims 4, 5, 6, 7, 8 or 9 to a subject in an amount sufficient to regulate blood glucose concentration in the subject.

11. The method of claim 9, wherein the subject is treated for diabetes mellitus.

22. The method of claim 10, wherein the subject is treated for diabetes mellitus.

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