Treatment type 2 diabetes mellitus patients

• US 10,434,147 B2
• Filed: 07/11/2017
• Issued: 10/08/2019
• Est. Priority Date: 03/13/2015
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Roy, Christine, Souhami, Elisabeth, Demil, Nacima, Ye, Jenny
• Primary Examiner(s): Ha, Julie
• Assistant Examiner(s): Hellman, Kristina M
• Application Number:
  US15/646,760
• Publication Number:
  US 20180092965A1
• Time in Patent Office: 819 Days
• Field of Search: None
• 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 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• 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 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A pharmaceutical combination for use in glycemic control in a type 2 diabetes mellitus patient, said combination comprising (i) lixisenatide or/and a pharmaceutically acceptable salt thereof, (ii) insulin glargine or/and a pharmaceutically acceptable salt thereof, and (iii) optionally metformin or/and a pharmaceutically acceptable salt thereof.

Claims

1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising:

administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising lixisenatide and insulin glargine;

wherein the patient has a body mass index (BMI)≥

30 kg/m² or has experienced a hypoglycemic event;

wherein the patient'"'"'s type 2 diabetes mellitus is not adequately controlled after treatment with basal insulin; and

wherein the patient requires additional glycemic control without the increase in hypoglycemia and weight gain of prandial insulin.

2. The method of claim 1, wherein the patient'"'"'s type 2 diabetes mellitus is not adequately controlled after treatment with basal insulin and metformin.

3. The method of claim 1, wherein the patient'"'"'s type 2 diabetes mellitus is not adequately controlled after treatment with basal insulin and one to three oral anti-diabetic drugs (OADs).

4. The method of claim 3, wherein the one to three OADs are selected from the group consisting of metformin, sulfonylureas, dipeptidyl-peptidase-4 (DPP-4) inhibitors, glinides, or combinations thereof.