Glibenclamide-metformin combination for the treatment of diabetes mellitus of type II

Abstract

Non-insulin dependent diabetes mellitus in cases of secondary failure is treated with a combination of glibenclamide and metformin.

Description

The present invention relates to the use of a combination consisting of glibenclamide and metformin in one specific ratio as medicament for the treatment of diabetes mellitus of type II.Non-insulin dependent diabetes of type II (NID) is known to be a frequent metabolic disease and the main cause of hyperglycemia. In recent years, diabetes mellitus of type II has been proved to be a heterogeneous disease, with complex, unclarified metabolic aspects, which disease is characterized by three main metabolic abnormalities contributing to hyperglycemia: the partial or complete decrease in insulin secretion, the resistance of the peripheral tissues to insulin and the increased hepatic production of glucose in fasting conditions.Diet and physical exertion are unanimously recognized to be the foundation of the therapy of diabetes of type II: both of them lead to a reduction in insulin-resistance and, in the long run, to an improvement in the pancreas secretive deficit.However, these provision...

AI Technical Summary

Benefits of technology

Now it has been found that a combination of glibenclamide and metformin (expressed as the hydrochloride) in a 1:100 weight ratio, so as to allow a daily administration of 15 mg of glibenclamide and 1500 mg of metformin, is suitable to the preparation of a medicament useful for the treatment of diabetes mellitus of type II at any time of the progression of the disease, from its onset to the most severe cases.

Therefore, it is an object of the present invention the use of the above mentioned combination in admixture with conventional carriers and excipients for the preparation of a medicament for the treatment of diabetes mellitus of type II, particularly in the cases "secondary failure" to a combination of glibenclamide-metformin currently used in therapy.

Problems solved by technology

However, these provisions are insufficient and a pharmacological aid with oral hypoglycemic agents is necessary.

Nevertheless, the efficacy of the therapy with oral hypoglycemic agents can decrease with time.

After a positive starting response which can last 4-5 years, monotherapy becomes ineffective in a considerable percentage of patients.

These are the so-called "secondary failures" of the therapy with oral hypoglycemic agents.

It should be noted, however, that none of these formulations attain the optimum therapeutical effect due to the quantitative unbalance of the medicaments in combination.

Therefore, the still unsolved problem is to find a combination capable of obtaining the maximum increase in the therapeutical effect with balanced doses of the single medicaments, thereby decreasing in parallel their untoward effects.