Treatment of Diabetes Mellitus by Long-Acting Formulations of Insulins
The application relates to an aqueous pharmaceutical formulation for use in the treatment of Type I or Type II Diabetes Mellitus, wherein the treatment reduces the risk of nocturnal hypoglycemia, said formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine, with the proviso that the concentration of said formulation is not 684 U/mL of insulin glargine.
1 . A method of treating Type I or Type II Diabetes Mellitus in a patient comprising administering to the patient an aqueous pharmaceutical formulation, wherein the aqueous pharmaceutical formulation comprises 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine, with the proviso that the concentration of insulin glargine is not 684 U/mL, wherein the time interval between administrations is in the range of 20 hours to 23.5 hours or in the range of 24.5 hours to 28 hours.
2 . The method of claim 1 , wherein the aqueous pharmaceutical formulation comprises 200 U/ml to 650 U/mL of insulin glargine [equimolar to 200-650 IU human insulin].
3 . The method of claim 1 , wherein the aqueous pharmaceutical formulation comprises 700 U/ml to 1000 U/mL of insulin glargine [equimolar to 700-1000 IU human insulin].
4 . The method of claim 2 , wherein the aqueous pharmaceutical formulation comprises 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin].
5 . The method of claim 4 , wherein the aqueous pharmaceutical formulation comprises 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
6 . The method of claim 1 , wherein the patient to be treated has a HbA1c value of at least 8% at the on set of treatment.
7 . The method of claim 1 , wherein the patient to be treated has a BMI of at least 30 kg/m 2 at the onset of treatment.
8 . The method of claim 1 , wherein the patient to be treated received a basal insulin directly prior to the treatment.
9 . The method of claim 1 , wherein the patient to be treated received a mealtime short-acting insulin directly prior to the treatment.
10 . The method of claim 1 , wherein the formulation is administered once daily in the evening at a predetermined time.
11 . The method of claim 1 , wherein the patient additionally receives a mealtime short-acting insulin.
12 . The method of claim 1 , wherein the aqueous pharmaceutical formulation comprises one or more excipients selected from the group consisting of zinc, m-cresol, glycerol, polysorbate 20, and sodium.
13 . The method of claim 12 , wherein the aqueous pharmaceutical formulation comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/ml glycerol 85%.
14 . The method of claim 12 , wherein the aqueous pharmaceutical formulation comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20 and 20 mg/mL glycerol 85%.
15 . The method of claim 1 , wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6.
16 . The method of claim 1 , wherein the Diabetes Mellitus is Type II Diabetes Mellitus.
17 . The method of claim 16 , wherein the Diabetes Mellitus Type II is not adequately controlled with at least one oral antihyperglycemic alone.
18 . The method of claim 17 , wherein the at least one oral antihyperglycemic is metformin.
19 . The method of claim 18 , wherein a treatment with at least 1.5 g/day of metformin does not adequately control the Diabetes Mellitus.
20 . The method of claim 17 , wherein the aqueous pharmaceutical formulation is administered in combination with at least one oral antihyperglycemic agent.
21 . The method of claim 20 , wherein the at least one antihyperglycemic agent is metformin.
22 . The method of claim 1 , wherein the aqueous pharmaceutical formulation is administered on at least two days per week.
23 . The method of claim 1 , wherein the aqueous pharmaceutical formulation is administered on at least three days per week.
24 . The method of claim 1 , wherein the aqueous pharmaceutical formulation is administered on at least four days per week.