Treatment Type 2 Diabetes Mellitus Patients

Patent metadata

Field	Value
Publication number	US-2016287674-A1
Application number	US-201615068286-A
Country	US
Kind code	A1
Filing date	Mar 11, 2016
Priority date	Mar 13, 2015
Publication date	Oct 6, 2016
Grant date	—

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.

First claim

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

2 . The pharmaceutical combination for use according to claim 1 , wherein the type 2 diabetes mellitus to be treated is not adequately controlled with compound (b) and optionally compound (c) alone.

3 . The pharmaceutical combination for use according to claim 1 , wherein the patient to be treated is obese.

4 . The pharmaceutical combination for use according to claim 1 , wherein the patient to be treated has an age of at least 65 years.

5 . The pharmaceutical combination for use according to claim 1 , wherein prior to the onset of therapy with the combination according to claim 1 , the patient has a fasting plasma glucose of at least 9 mmol/L when treated with a basal insulin monotherapy or a basal insulin and one to three oral anti-diabetics alone selected from the group consisting of metformin, a sulfonylurea, a DPP-4 inhibitor or a glinide alone.

6 . The pharmaceutical combination for use according to claim 1 , wherein prior to the onset of therapy with the combination according to claim 1 , the patient has a fasting plasma glucose concentration in the range of 5.6 to 6.9 mmol/L or a fasting plasma glucose concentration of at least 6.6 mmol/L when treated with compound (b) and optionally compound (c) alone.

7 . The pharmaceutical combination for use according to claim 1 , wherein prior to the onset of therapy with the combination according to claim 1 , the patient has a HbA1c of at least 8.5% when treated with a basal insulin monotherapy or a basal insulin and one to three oral anti-diabetics alone selected from the group consisting of metformin, a sulfonylurea, a DPP-4 inhibitor or a glinide alone.

8 . The pharmaceutical combination for use according to claim 1 , wherein prior to the onset of therapy with the combination according to claim 1 , the patient has a HbAlc of at least 7.5% when treated with compound (b) and optionally compound (c) alone.

9 . The pharmaceutical combination for use according to claim 5 , wherein the basal insulin is selected from insulin glargine, insulin detemir and isophane insulin (NPH insulin).

10 . The pharmaceutical combination for use according to claim 1 , wherein the patient does not receive concomitant treatment with at least one of a sulfonylurea, a DPP-4 inhibitor and a glinide.

11 . The pharmaceutical combination for use according to claim 1 , wherein in the type 2 diabetes mellitus patient to be treated has been diagnosed for at least 1 year or at least 2 years prior to the onset of a therapy with compounds (a), (b) and optionally (c).

12 . The pharmaceutical combination for use according to claim 1 , wherein the administration of the combination comprises the steps:
(i) administration of compounds (b) and (c) for at least 4 weeks, and (ii) continuing treatment by administration of compounds (a), (b) and (c), wherein the amount of compound (b) to be administered in step (i) is adjusted so that a predetermined fasting plasma glucose level or/and a predetermined self-monitored plasma glucose level is reached or at least approximated.

13 . The pharmaceutical combination for use according to claim 12 , wherein the amount of compound (b) to be administered in step (i) is adjusted so that
(I) a fasting plasma glucose level or/and a fasting self-monitored plasma glucose level of about 4.4 mmol/l to about 5.6 mmol/l, or/and (II) a self-monitored plasma glucose level (SMPG) of about 7.8 mmol/1 (or about 140 mg/dl) or less is reached or at least approximated.

14 . The pharmaceutical combination for use according to claim 13 , wherein the self-monitored plasma glucose level in (II) is a 4-point self-monitored plasma glucose level or a 7-point self-monitored plasma glucose level.

15 . The pharmaceutical combination for use according to claim 1 , wherein
(a) lixisenatide or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration, (b) insulin glargine or/and or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration, or/and (c) metformin or/and the pharmaceutically acceptable salt thereof is prepared for oral administration.

Assignees

• Sanofi Aventis Deutschland

Inventors

• Roy Christine
• Souhami Elisabeth
• Demil Nacima
• Ye Jenny

Classifications

• A61K31/155

  Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2) · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K38/26 Primary

  Glucagons · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title