Rapid establishment and/or termination of substantial steady-state drug delivery
First Claim
1. A method for treating type 2 diabetes mellitus in a human subject, the method comprising:
- implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device, wherein(i) continuous administration comprises a first continuous administration period of the incretin mimetic at a first mcg/day dose, followed by a second continuous administration period of the incretin mimetic at a second mcg/day dose, wherein the second mcg/day dose is greater than the first mcg/day dose,(ii) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device,(iii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months,(iv) the first mcg/day dose followed by the second mcg/day dose is about 20 mcg/day followed by about 60 mcg/day, and(v) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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Abstract
The present invention is directed to treatment methods for a disease or condition, in a subject in need of such treatment, that provide alternatives to treatment by injection that give, relative to treatment by injection, improved treatment outcomes, 100% treatment compliance, reduced side effects, and rapid establishment and/or termination of substantial steady-state drug delivery. The method typically includes providing continuous delivery of a drug from an implanted osmotic delivery device, wherein substantial steady-state delivery of the drug at therapeutic concentrations is typically achieved within about 7 days or less after implantation of the osmotic delivery device in the subject and the substantial steady-state delivery of the drug from the osmotic delivery device is continuous over a period of at least about 3 months. In one embodiment, the present invention is directed to treatment of type 2 diabetes mellitus using incretin mimetics.
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Citations
34 Claims
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1. A method for treating type 2 diabetes mellitus in a human subject, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device, wherein (i) continuous administration comprises a first continuous administration period of the incretin mimetic at a first mcg/day dose, followed by a second continuous administration period of the incretin mimetic at a second mcg/day dose, wherein the second mcg/day dose is greater than the first mcg/day dose, (ii) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (iii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, (iv) the first mcg/day dose followed by the second mcg/day dose is about 20 mcg/day followed by about 60 mcg/day, and (v) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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2. A method for reducing body weight, treating obesity, suppressing appetite or facilitating weight loss in a human subject, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device, wherein (i) continuous administration comprises a first continuous administration period of the incretin mimetic at a first mcg/day dose, followed by a second continuous administration period of the incretin mimetic at a second mcg/day dose, wherein the second mcg/day dose is greater than the first mcg/day dose, (ii) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (iii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, (iv) the first mcg/day dose followed by the second mcg/day dose is about 20 mcg/day followed by about 60 mcg/day, and (v) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator. - View Dependent Claims (9, 10, 11, 12)
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3. A method for reducing HbA1c plasma concentration, reducing systolic blood pressure, reducing LDL-C, reducing glucose levels, or reducing fructosamine levels in a human subject, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device, wherein (i) continuous administration comprises a first continuous administration period of the incretin mimetic at a first mcg/day dose, followed by a second continuous administration period of the incretin mimetic at a second mcg/day dose, wherein the second mcg/day dose is greater than the first mcg/day dose, (ii) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (iii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, (iv) the first mcg/day dose followed by the second mcg/day dose is about 20 mcg/day followed by about 60 mcg/day, and (v) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator. - View Dependent Claims (13, 14, 15, 16, 17)
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4. A method for mitigating nausea in a human subject, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device, wherein (i) continuous administration comprises a first continuous administration period of the incretin mimetic at a first mcg/day dose, followed by a second continuous administration period of the incretin mimetic at a second mcg/day dose, wherein the second mcg/day dose is greater than the first mcg/day dose, (ii) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (iii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, (iv) the first mcg/day dose followed by the second mcg/day dose is about 20 mcg/day followed by about 60 mcg/day, and (v) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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5. A method for treating type 2 diabetes mellitus in a human subject who has been administered an incretin mimetic during a first administration period at a first mcg/day dose, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device during a second continuous administration period at a second mcg/day dose that is 60 mcg/day, wherein (i) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (ii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, and (iii) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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6. A method for reducing body weight, treating obesity, suppressing appetite or to facilitate weight loss in a human subject who has been administered an incretin mimetic during a first administration period at a first mcg/day dose, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device during a second continuous administration period at a second mcg/day dose that is 60 mcg/day, wherein (i) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (ii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, and (iii) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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7. A method for reducing HbA1c plasma concentration, reducing LDL-C, reducing systolic blood pressure, reducing glucose levels, or reducing fructosamine levels in a human subject who has been administered an incretin mimetic during a first administration period at a first mcg/day dose, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device during a second continuous administration period at a second mcg/day dose that is 60 mcg/day, wherein (i) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (ii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, and (iii) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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8. A method for mitigating nausea in a human subject who has been administered an incretin mimetic during a first administration period at a first mcg/day dose, the method comprising:
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implanting in the human subject at least one osmotic delivery device comprising an incretin mimetic to provide continuous administration of the incretin mimetic from the at least one osmotic delivery device during a second continuous administration period at a second mcg/day dose that is 60 mcg/day, wherein (i) substantial steady-state delivery of the incretin mimetic at a therapeutic concentration is achieved within about 5 days after each implantation of an osmotic delivery device, (ii) substantial steady-state delivery of the incretin mimetic is continuous for at least about 3 months, and (iii) the osmotic delivery device comprises a cylindrical reservoir that is capped at one end by a controlled-rate, semi-permeable membrane and capped at the other end by a diffusion moderator.
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Specification