Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
First Claim
1. A method of treating type 2 diabetes mellitus in a subject having a baseline hemoglobin A1c (HbA1c) % of greater than 10.0% comprising measuring a subject'"'"'s baseline body weight and providing the subject a substantial steady-state delivery of a dose of at least 20 mcg/day of an exenatide from an osmotic delivery device, wherein the substantial steady-state delivery of the exenatide from the osmotic delivery device is continuous over an administration period of at least about 1 month, the method produces a decrease in the body weight of the subject of at least 3% relative to the subject'"'"'s baseline body weight, and the decrease in the subject'"'"'s body weight is achieved within 39 weeks after implantation of the osmotic delivery device.
5 Assignments
0 Petitions
Accused Products
Abstract
The present invention is directed to treatments for a disease or condition, in a subject in need thereof, 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 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 achieved within about 7 days 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 insulinotrophic peptides. In embodiments, a subject has a baseline HbA1c % of greater than 6.5% or 10.0%.
753 Citations
27 Claims
- 1. A method of treating type 2 diabetes mellitus in a subject having a baseline hemoglobin A1c (HbA1c) % of greater than 10.0% comprising measuring a subject'"'"'s baseline body weight and providing the subject a substantial steady-state delivery of a dose of at least 20 mcg/day of an exenatide from an osmotic delivery device, wherein the substantial steady-state delivery of the exenatide from the osmotic delivery device is continuous over an administration period of at least about 1 month, the method produces a decrease in the body weight of the subject of at least 3% relative to the subject'"'"'s baseline body weight, and the decrease in the subject'"'"'s body weight is achieved within 39 weeks after implantation of the osmotic delivery device.
- 20. A method of treating type 2 diabetes mellitus in a subject having a baseline hemoglobin A1c (HbA1c) % of greater than 10.0% comprising providing the subject a substantial steady-state delivery of a dose of at least 20 mcg/day of an exenatide from an osmotic delivery device, wherein the substantial steady-state delivery of the exenatide from the osmotic delivery device is continuous over an administration period of at least about 1 month, the method produces a decrease in the body weight of the subject of at least 3% relative to the subject'"'"'s baseline body weight upon implantation of the osmotic delivery device, and the decrease in the subject'"'"'s body weight is achieved within 39 weeks after implantation of the osmotic delivery device.
- 22. A method of treating type 2 diabetes mellitus in a population having a mean baseline hemoglobin A1c (HbA1c) % of greater than 10.0% comprising measuring a population'"'"'s mean baseline body weight and providing the population a substantial steady-state delivery of a dose of at least 20 mcg/day of an exenatide from an osmotic delivery device, wherein the substantial steady-state delivery of the exenatide from the osmotic delivery device is continuous over an administration period of at least about 1 month, the method produces a decrease in the mean body weight of the population of at least 3% relative to the population'"'"'s mean baseline body weight, and the decrease in the population'"'"'s body weight is achieved within 39 weeks after implantation of the osmotic delivery device.
Specification