Method for treating diabetes
AssigneeBristol-Myers Squibb Company
InventorBeth Anne Piper
Life of this patent
Estimating the term…
Abstract
A method is provided for first line treatment of type 2 diabetes employing a combination of metformin and glyburide. A method for treating diabetes in drug naive human patients is also provided employing the above formulation to reduce insulin resistance and/or post-prandial glucose excursion and/or hemoglobin 1Ac, and/or increase post-prandial insulin, thereby treating the diabetes.
Claims9
A method for first line treatment of type 2 diabetes, in a drug naïve human patient who has had no previous oral hyperglycemic treatment, which comprises administering to a drug naïve human patient in need of treatment, as first line therapy, a low dose of a combination of metformin and glyburide in a single dosage form, wherein the starting daily dosage is 250 mg metformin and 1.25 mg glyburide, where the glyburide has a particle size distribution so that at most 25% of the particles of the glyburide are less than 11 μm and at most 25% of the particles of the glyburide are greater than 46 μm, wherein after the staffing daily dosage, the metformin in said low dose combination is administered in a daily dosage in an amount within the range from about 250 mg to about 750 mg, and the glyburide in said low dose combination is administered in a daily dosage in an amount within the range from about 0.5 mg to about 15 mg, and wherein the weight ratio of metformin to glyburide is about 200:1, wherein the low dose combination of metformin and glyburide provides at least substantially equivalent efficacy in treating type 2 diabetes in drug naïve patients, but with substantially reduced side effects as compared to prior art combinations of metformin and glyburide employed in substantially higher daily dosages.
A method for lowering blood glucose in a hyperglycemic human patient, decreasing insulin resistance, decreasing hemoglobin A1c, increasing post-prandial insulin levels or decreasing post-prandial glucose excursion, individually or in any combination, in a human patient, which comprises administering to a drug naïve human patient, who has had no previous oral hyperglycemic treatment, as first line therapy, a therapeutically effective amount of a low dose of a combination of metformin and glyburide in a single dosage form, wherein the starting daily dosage is 250 mg metformin and 1.25 mg glyburide where the glyburide has a particle size distribution so that at most 25% of the particles of the glyburide are less than 11 μm and at most 25% of the particles of the glyburide are greater than 46 μm, wherein after the starting daily dosage, the metformin in said low dose combination is administered in a daily dosage from about 250 mg to about 750 mg, wherein the weight ratio of metformin to glyburide is about 200:1, wherein the low dose combination of metformin and glyburide provides at least substantially equivalent efficacy in treating type 2 diabetes in drug naïve patients, but with substantially reduced side effects, as compared to prior art combinations of metformin and glyburide employed in substantially higher daily dosages.
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