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Preparation and method for treating diabetes

A diabetes and preparation technology, applied in the field of low-dose pharmaceutical preparations, can solve problems such as unsatisfactory blood sugar control

Inactive Publication Date: 2008-10-01
BRISTOL MYERS SQUIBB CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] (5) Metformin-sulfonylurea combination therapy for moderate NIDDM patients with unsatisfactory blood sugar control, Reaven et al., J.Clin.Endocrinol.Metab.(74, Issue 5, 1020-26, 1992)
[0025] None of the above literatures suggest that antidiabetic combinations, including metformin, should be used as first-line treatment in drug-naive patients

Method used

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  • Preparation and method for treating diabetes
  • Preparation and method for treating diabetes
  • Preparation and method for treating diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 and 2

[0123] Tablets containing the metformin / glibenclamide combination were prepared as described below.

[0124] Metformin hydrochloride-glibenclamide tablet composition

[0125] 250mg / 1.25mg and 500mg / 2.5

Embodiment 1            Embodiment 2

[0127]

[0128] * HPMC type film coating is used.

[0129] Metformin hydrochloride-glibenclamide tablet preparations 250mg / 1.25mg and 500mg / 2.5mg were compressed using the same granulation method. Compress small size tablets of half the weight of the 500mg / 2.5mg metformin hydrochloride-glibenclamide tablet. Tablets produced for clinical use are film coated with a hydroxypropylmethylcellulose (HPMC) film coating. The film coating is non-functional and suitable for anesthesia purposes. The abovementioned film coatings are known to be suitable for use in clinical preparations.

[0130] The production methods for processed clinical products are as follows:

[0131] The croscarmellose sodium and glibenclamide were dispersed together using a high shear mixer and then mixed with metformin hydrochloride / magnesium stearate (99.5%:0.5% w / w). The dry mixture obtained is granulated with an aqueous solution of polyvinylpyrrolidone in a high shear mixer and then dried in a fluid bed...

Embodiment 3

[0143] A. Overview of 5 clinical protocols

[0144] (1. Purpose

[0145] The purpose of the following study was to compare 2 dosage strengths of the fixed combination metformin / glibenclamide product (products described in Examples 1 and 2) with placebo in drug-naïve patients with type 2 diabetes who cannot control their blood sugar with diet and exercise. blood sugar control. Dosage strengths of the fixed combination drugs evaluated included 250 mg metformin and 1.25 mg glyburide, and 500 mg metformin and 2.5 mg glibenclamide. The most important standard measure of long-term blood glucose control is hemoglobin Alc (HbAlc) to evaluate blood glucose control. Compare the average change value of HbAlc after 20 weeks of treatment (4 weeks of stable daily medication, 4 weeks of gradually increasing dose and 12 weeks of stable administration). Treatment was continued for an additional 12 weeks in order to assess the durability of the effect.

[0146] The effects of the indivi...

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Abstract

A low dose antidiabetic pharmaceutical formulation is provided, especially adapted for treating Type II diabetes in drug naive patients, which includes a combination of metformin (employed in a reduced amount (less than 800 mg metformin per day) compared to that employed in generally accepted medical practice) and at least one other antidiabetic agent such as a sulfonyl urea, for example, glyburide, which combination provides at least about substantially equivalent efficacy in treating diabetes in drug naive patients, as do antidiabetic formulations containing metformin employed in dosages prescribed in generally accepted medical practice for first line therapy in treating diabetes, but with substantially reduced side effects, such as hypoglycemia and / or gastrointestinal distress. 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.

Description

[0001] This application is a divisional case of the Chinese patent application (National Application No. 00818028.8, International Application No. PCT / US00 / 28467) entitled "Antidiabetic Preparations and Methods" filed on October 13, 2000 Apply. technical field [0002] The present invention relates to a low-dose pharmaceutical formulation for the treatment of drug-naive type 2 diabetic patients comprising metformin (preferably in an amount lower than that used in generally accepted medical practice) and another antidiabetic agent, such as a sulfonylurea (eg, Glibenclamide), the efficacy of the preparation for treating diabetes is at least approximately the same as that of metformin anti-diabetic preparations in the prior art, but the side effects are significantly reduced, and the present invention also relates to a method for using the preparation for treating diabetes. Background technique [0003] U.S. Patent No. 3,174,901 discloses the biguanide antihyperglycemic drug me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/155A61K31/64A61P3/10A61K9/14A61K31/18A61K31/427A61K45/06A61P1/00A61P1/08A61P1/12
CPCA61K45/06A61K31/155Y10S514/866A61K31/64A61P1/00A61P1/08A61P1/12A61P3/00A61P43/00A61P5/50A61P3/10A61K2300/00
Inventor B·A·皮佩尔
Owner BRISTOL MYERS SQUIBB CO
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