USE OF AVE0010 FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF DIABETES MELLITUS TYPE 2
The present invention refers to the use of Lixisenatide or/and a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for the treatment of diabetes mellitus type 2, for inducing weight loss in diabetes type 2 patients or/and for preventing weight gain in diabetes type 2 patients.
1 . A method of treating diabetes mellitus type 2 in a patient in need thereof comprising administering to said patient a therapeutically effective amount of desPro 36 Exendin-4(1-39)-Lys 6 -NH 2 or/and a pharmaceutically acceptable salt thereof.
2 . The method according to claim 1 , wherein the patient to be treated is obese.
3 . The method according to claim 1 , wherein the patient to be treated has a body mass index of at least 30 kg/m 2 .
4 . The method according to claim 1 , wherein the patient to be treated is an adult subject.
5 . The method according to claim 1 , wherein the patient to be treated does not receive an antidiabetic treatment.
6 . The method according to claim 1 , wherein in the patient to be treated, diabetes mellitus type 2 has been diagnosed at least 1 year or at least 2 years before onset of therapy.
7 . The method according to claim 1 , wherein the patient to be treated has a HbA 1c value of about 7 to about 10%.
8 . The method according to claim 1 , wherein the patient to be treated has a fasting plasma glucose concentration of at least 8 mmol/L.
9 . The method according to claim 1 , wherein the patient to be treated has a 2 hours postprandial plasma glucose concentration of at least 10 mmol/L.
10 . The method according to claim 1 , wherein the subject patient to be treated has a glucose excursion of at least 2 mmol/L, wherein the glucose excursion is the difference of the 2 hours postprandial plasma glucose concentration and plasma glucose concentration 30 minutes prior to a meal test.
11 . The method according to claim 1 , wherein the desPro 36 Exendin-4(1-39)-Lys 6 -NH 2 or/and the pharmaceutically acceptable salt thereof is administered parenterally.
12 . The method according to claim 1 , wherein the desPro 36 Exendin-4(1-39)-Lys 6 -NH 2 or/and the pharmaceutically acceptable salt thereof is prepared for administration in a daily dose selected from the range of 10 μg to 20 μg.
13 . A pharmaceutical composition comprising desPro 36 Exendin-4(1-39)-Lys 6 -NH 2 or/and a pharmaceutically acceptable salt thereof, and optionally comprising pharmaceutically acceptable carriers, adjuvants, or/and auxiliary substances.
14 . A method of treating diabetes mellitus type 2, for use in inducing weight loss in diabetes type 2 patients or/and for use in preventing weight gain in diabetes type 2 patients comprising administering to said patient a therapeutically effective amount of the pharmaceutical composition of claim 13 .
15 . (canceled)
16 . (canceled)
17 . (canceled)
18 . The method according to claim 1 , wherein the patient to be treated has a 2 hours postprandial plasma glucose concentration of at least 12 mmol/L.
19 . The method according to claim 1 , wherein the patient to be treated has a 2 hours postprandial plasma glucose concentration of at least 14 mmol/L.
20 . The method according to claim 10 , wherein the patient to be treated has a glucose excursion of at least 3 mmol/L.
21 . The method according to claim 10 , wherein the patient to be treated has a glucose excursion of at least 4 mmol/L.
22 . The method according to claim 10 , wherein the patient to be treated has a glucose excursion of at least 5 mmol/L.