Methods for treating diabetes via administration of controlled release metformin
DCFirst Claim
1. A method for lowering blood glucose levels in human patients needing treatment for non-insulin-dependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once-a-day basis at least one oral controlled release dosage form comprising an effective dose of metformin or a pharmaceutically acceptable salt thereof and an effective amount of a controlled release carrier to control the release of said metformin or pharmaceutically acceptable salt thereof from said dosage form, wherein following oral administration of a single dose, the dosage form provides a mean time to maximum plasma concentration (Tmax) of metformin at from 5.5 to 7.5 hours after administration following dinner;
- and the administration of the at least one metformin dosage form provides a mean AUC0-24 of 22590±
3626 ng·
hr/ml and a mean Cmax of 2435±
630 ng/ml on the first day of administration and a mean AUC0-24 of 24136±
7996 ng·
hr/ml and a mean Cmax of 2288±
736 np/ml on the 14th day of administration, for administration of a 2000 mg once-a-day dose of metformin.
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Litigations
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Accused Products
Abstract
A method for treating patients having non-insulin-dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once-a-day basis. The dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at a 5.5 to 7.5 hours after oral administration on a once-a-day basis to human patients. Preferably, the dose of drug is administered at dinnertime to a patient in the fed state.
173 Citations
21 Claims
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1. A method for lowering blood glucose levels in human patients needing treatment for non-insulin-dependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once-a-day basis at least one oral controlled release dosage form comprising an effective dose of metformin or a pharmaceutically acceptable salt thereof and an effective amount of a controlled release carrier to control the release of said metformin or pharmaceutically acceptable salt thereof from said dosage form, wherein following oral administration of a single dose, the dosage form provides a mean time to maximum plasma concentration (Tmax) of metformin at from 5.5 to 7.5 hours after administration following dinner;
- and the administration of the at least one metformin dosage form provides a mean AUC0-24 of 22590±
3626 ng·
hr/ml and a mean Cmax of 2435±
630 ng/ml on the first day of administration and a mean AUC0-24 of 24136±
7996 ng·
hr/ml and a mean Cmax of 2288±
736 np/ml on the 14th day of administration, for administration of a 2000 mg once-a-day dose of metformin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- and the administration of the at least one metformin dosage form provides a mean AUC0-24 of 22590±
Specification