Treatment protocol of diabetes type 2
OwnerLouise SILVESTRE, Elisabeth SOUHAMI +1inventors
InventorsLouise SILVESTRE, Elisabeth SOUHAMI, Xiaodan WEI
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Abstract
The present invention refers to a treatment protocol for diabetes type 2 patients.
Claims28
A pharmaceutical combination for use in the treatment of a diabetes type 2 patient, wherein the diabetes type 2 is insufficiently controlled by at least one oral antidiabetic drug, said combination comprising
- (a) desPro36Exendin-4(1-39)-Lys6-NH2 or/and a pharmaceutically acceptable salt thereof;
- (b) insulin glargine or/and pharmaceutically acceptable salt thereof, and
- (c) metformin or/and a pharmaceutically acceptable salt thereof,
- wherein the treatment of the diabetes type 2 patient 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 steps (i) or/and (ii) 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.
The pharmaceutical combination of any one of the preceding claims, wherein steps (i) or/and (ii) further comprise the administration of a thiazolidinedione.
The pharmaceutical combination of any one of the preceding claims, wherein administration in steps (i) or/and (ii) is performed on a daily basis.
The pharmaceutical combination of any one of the preceding claims, wherein the amount of compound (b) to be administered in steps (i) or/and (ii) is adjusted on the basis of daily measurements of plasma glucose concentration.
The pharmaceutical combination of any one of the preceding claims, wherein the amount of compound (b) to be administered in steps (i) or/and (ii) is adjusted so that a fasting plasma glucose level of about 4.4 mmol/l to about 5.6 mmol/l or/and a self monitored plasma glucose level of about 8 mmol/l is reached or at least approximated.
The pharmaceutical combination of any one of the preceding claims, wherein the treatment of a diabetes type 2 patient improves glycemic control in a diabetes type 2 patient.
The pharmaceutical combination of any one of the preceding claims, wherein the treatment of a diabetes type 2 patient improves self-monitored plasma glucose.
The pharmaceutical combination of any one of the preceding claims, wherein the treatment of a diabetes type 2 patient induces weight loss or/and prevents weight gain.
The pharmaceutical combination of any one of the preceding claims, wherein the treatment of a diabetes type 2 patient prevents hypoglycemia.
The pharmaceutical combination according to any one of the preceding claims, wherein the patient to be treated is obese.
The pharmaceutical combination according to any one of the preceding claims, wherein the patient to be treated has a body mass index of at least 30 kg/m2.
The pharmaceutical combination according to any one of the preceding claims, wherein the patient to be treated is an adult patient.
The pharmaceutical combination according to any one of the preceding claims, wherein the patient to be treated does not receive a treatment by an insulin or/and a pharmaceutically acceptable salt thereof at the onset of step (i).
The pharmaceutical combination of any one of the preceding claims, 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.
The pharmaceutical combination of any one of the preceding claims, wherein the patient to be treated has a HbA1c value of about 7 to about 10%.
The pharmaceutical combination of any one of the preceding claims, wherein at the onset of step (i), the patient has fasting plasma glucose concentration of at least 8 mmol/L.
The pharmaceutical combination of any one of the preceding claims, wherein at the onset of step (i), the patient has a 2 hours postprandial plasma glucose concentration of at least 10 mmol/L, at least 12 mmol/L, or at least 14 mmol/L.
The pharmaceutical combination of any one of the preceding claims, wherein at the onset of step (i), the patient has a glucose excursion of at least 2 mmol/L, at least 3 mmol/L, at least 4 mmol/L or at least 5 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.
The pharmaceutical combination of any one of the preceding claims, wherein the desPro36Exendin-4(1-39)-Lys6-NH2 or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration.
The pharmaceutical combination according to any of the preceding claims, wherein the insulin glargine or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration.
The pharmaceutical combination according to any one of the preceding claims, wherein the desPro36Exendin-4(1-39)-Lys6-NH2 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.
The pharmaceutical combination of any one of the preceding claims, wherein the metformin or/and the pharmaceutically acceptable salt thereof is prepared for oral administration.
A method for treatment of a diabetes type 2 patient, wherein the diabetes type 2 is insufficiently controlled by at least one oral antidiabetic drug, wherein the method comprises the administration of a combination, said combination comprises
- (a) desPro36Exendin-4(1-39)-Lys6-NH2 or/and a pharmaceutically acceptable salt thereof,
- (b) insulin glargine or/and pharmaceutically acceptable salt thereof, and
- (c) metformin or/and a pharmaceutically acceptable salt thereof,
- 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 steps (i) or/and (ii) 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.
Dependencies are inferred from the claim text.