Treatment of Type 2 Diabetes Mellitus Patients

Patent metadata

Field	Value
Publication number	US-2016296601-A1
Application number	US-201615073364-A
Country	US
Kind code	A1
Filing date	Mar 17, 2016
Priority date	Mar 18, 2015
Publication date	Oct 13, 2016
Grant date	—

Abstract

The present invention refers to lixisenatide for use in the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient.

First claim

1 . A method for the reduction of urinary albumin excretion in a type 2 diabetes mellitus patient, said method comprising administering lixisenatide and/or a pharmaceutically acceptable salt thereof to the patient.

2 . A method for the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient, said method comprising administering lixisenatide and/or a pharmaceutically acceptable salt thereof to the patient.

3 . The method according to claim 1 or 2 , wherein the patient has experienced at least one acute coronary syndrome event.

4 . The method according to claim 1 , wherein the patient suffers from microalbuminuria with an urinary albumin to creatinine ratio of ≧30 to <300 mg/g.

5 . The method according to claim 1 , wherein the patient suffers from macroalbuminuria with an urinary albumin to creatinine ratio of ≧2300 mg/g.

6 . The method according to claim 1 , wherein the patient suffers from mild renal impairment with a glomerular filtration rate of ≧60 to <90 mL/min/1.73 m 2 .

7 . The method according to claim 1 , wherein the patient suffers from a moderate renal impairment with a glomerular filtration rate of ≧30 to <60 mL/min/1.73 m 2 .

8 . The method according to claim 1 , wherein the patient suffers from a severe renal impairment with a glomerular filtration rate of ≧15 to <30 mL/min/1.73 m 2 .

9 . A method for the reduction of cardiovascular morbidity and/or cardiovascular mortality in a type 2 diabetes mellitus patient who has experienced at least one acute coronary syndrome event, said method comprising administering lixisenatide and/or a pharmaceutically acceptable salt thereof to the patient.

10 . (canceled)

11 . The method according to claim 9 , wherein the reduction of cardiovascular morbidity and/or cardiovascular mortality comprises a reduction of the risk of a cardiovascular event.

12 . (canceled)

13 . The method according to claim 9 , wherein the cardiovascular event includes death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, hospitalization for unstable angina, non-fatal heart failure, hospitalization for heart failure and/or coronary revascularization procedure.

14 . The method according to claim 9 , wherein the patient experienced the acute coronary syndrome event within 6 months prior to the onset of treatment with lixisenatide and/or the pharmaceutically acceptable salt thereof.

15 . The method according to claim 9 , wherein the acute coronary syndrome event has been diagnosed within 6 months prior to the onset of treatment with lixisenatide and/or the pharmaceutically acceptable salt thereof.

16 . The method according to claim 9 , wherein the acute coronary syndrome event is a spontaneous acute coronary syndrome event.

17 . The method according to claim 9 , wherein the acute coronary syndrome event comprises an ST-segment or a non-ST-segment elevation myocardial infarction.

18 . (canceled)

19 . The method according to claim 9 , wherein the acute coronary syndrome event comprises an unstable angina.

20 . The method according to claim 9 , wherein the patient further comprises a risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, hospitalization for unstable angina, non-fatal heart failure, hospitalization for heart failure and/or coronary revascularization procedure.

21 . (canceled)

22 . The method according to claim 20 , wherein the revascularization procedure is percutaneous coronary intervention or coronary artery bypass grafting.

23 . The method according to claim 9 , wherein the blood plasma concentration of hs-CRP, BNP and/or NT-proBNP is reduced by the treatment with lixisenatide and/or the pharmaceutically acceptable salt thereof.

24 . (canceled)

25 . (canceled)

26 . The method according to claim 9 , wherein the type 2 diabetes mellitus patient has been diagnosed with a cardiovascular disease prior to the acute coronary syndrome.

27 . The method according to claim 26 , wherein the cardiovascular disease comprises coronary heart disease, cerebrovascular disease, peripheral artery disease, and/or cardiac arrhythmia.

28 . The method according to claim 1 or 9 , wherein the patient receives lixisenatide and/or a pharmaceutically acceptable salt thereof in combination with
(a) metformin and/or a pharmaceutically acceptable salt thereof,
(b) insulin and/or a pharmaceutically acceptable salt thereof,
(c) a glinide and/or a pharmaceutically acceptable salt thereof,
(d) a sulfonylurea and/or a pharmaceutically acceptable salt thereof.

29 . (canceled)

30 . The method according to claim 1 or 9 , wherein the patient has a body mass index of at least 30 kg/m 2 .

31 . The method according to claim 1 or 9 , wherein prior to the onset of treatment with lixisenatide and/or the pharmaceutically acceptable salt thereof, the patient has a fasting plasma glucose concentration of at least 8 mmol/L.

32 . The method according to claim 1 or 9 , wherein prior to the onset of treatment with lixisenatide and/or the pharmaceutically acceptable salt thereof, the patient has a HbA1c value of at least about 7%.

Assignees

• Sanofi Aventis Deutschland

Inventors

• Belder Rene
• Johnston Peter
• Lawson Francesca
• Ping Lin
• Wei Xiaodan

Classifications

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P5/50

  for increasing or potentiating the activity of insulin · CPC title

• A61P43/00

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

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61P9/04

  Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure · CPC title