Pre-mixes of GLP-1 and basal insulin

• US 7,238,663 B2
• Filed: 08/23/2002
• Issued: 07/03/2007
• Est. Priority Date: 08/28/2001
• Status: Expired due to Fees

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Ng, Kingman, DiMarchi, Richard Dennis, DeFelippis, Michael Rosario
• Primary Examiner(s): Tsang; Cecilia J.
• Assistant Examiner(s): AUDET, MAURY A
• Application Number:
  US10/486,333
• Publication Number:
  US 20040235710A1
• Time in Patent Office: 1,775 Days
• Field of Search: 514/12, 514/3
• US Class Current: 514/6.5
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present invention encompasses pre-mixed formulations comprising a GLP-1 polypeptide and a basal insulin.

Claims

1. A pre-mixed formulation comprising a GLP-1 compound and an acylated basal insulin wherein the GLP-1 compound is Arg³⁴Lys²⁶-(N-ε

-(γ

-Glu(N-α

-hexadecanoyl)))-GLP-1(7-37) and the acylated basal insulin is Nε

B29-tetradecanoyl des(B30) human insulin.

2. A process of preparing the pre-mixed formulation of claim 1, wherein the process comprises the steps of mixing said GLP-1 compound with said basal insulin in an aqueous medium.

3. A method of treating a condition selected from the group consisting of non-insulin dependent diabetes and insulin dependent diabetes comprising administering an effective amount of a pre-mixed formulation of claim 1 to a patient in need thereof.