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Takeda Pharmaceutical Company Limited has received approval from the Japanese Ministry of Health, Labour and Welfare for an additional indication of “BASEN® Tablets 0.2” and “BASEN® OD Tablets 0.2” (generic name: voglibose, hereinafter “BASEN”) for prevention of the onset of type 2 diabetes in patients with impaired glucose tolerance[*] (“IGT”), the first of its kind in Japan
Osaka, Japan | October 19, 2009 | Takeda Pharmaceutical Company Limited (“Takeda”) announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare for an additional indication of “BASEN® Tablets 0.2” and “BASEN® OD Tablets 0.2” (generic name: voglibose, hereinafter “BASEN”) for prevention of the onset of type 2 diabetes in patients with impaired glucose tolerance[*] (“IGT”), the first of its kind in Japan.
Launched in 1994 in Japan as a therapeutic agent for diabetes, BASEN improves postprandial hyperglycemia with its mechanism of action of delaying the digestion and absorption of carbohydrates in the small intestine. This additional indication has been approved based on the clinical evidence with Japanese subjects which shows preventive effects against the onset of type 2 diabetes when BASEN is administered to patients with IGT. That evidence was published in “The Lancet”, one of the most prestigious science magazines in the world.
Developing in the pre-diabetic stage, IGT increases the risk of the onset of diabetes and cardiovascular diseases. Although dietary treatment and/or exercise therapy is conducted for IGT patients, there are cases in which sufficient effects are not attained. The new treatment option of medicinal therapy presented by BASEN is expected to prevent the onset of diabetes more effectively.
Takeda is marketing in Japan three kinds of antidiabetic drugs, each with different mechanisms of action, namely, ACTOS®(generic name: pioglitazone), BASEN, and GLUFAST®(generic name: mitiglinide), and is able to offer to healthcare providers the optimal therapy for the pathologic conditions of individual patients. Now that BASEN has been approved for the additional indication for “prevention of the onset of type 2 diabetes in patients with IGT,” we believe that our products will be able to contribute to an even greater population of diabetes patients.
INDICATIONS
Prevention of type 2 diabetes mellitus in patients with IGT (for whom glycemic control is not sufficient by diet and/or exercise)
DOSAGE AND ADMINISTRATION
Prevention of type 2 diabetes mellitus in patients with IGT
(BASEN® Tablets 0.2 mg and BASEN® Tablets OD 0.2 mg only)
Usually for adults, a single doses of 0.2 mg as voglibose is orally administered three times a day prior to each meal.
PRECAUTIONS FOR USE
Use of this drug should be limited to patients who have been diagnosed with IGT (fasting plasma glucose < 6.9 mmol/L and 2 hours post 75g oral glucose tolerance test of between 7.8 and 11.0mmol/L) that has not been improved after a 3- ~ 6-month period of diet and/or exercise and who have at least one of the risk factors of: hypertension, dyslipidemia (hypertriglycemia, hypo-HDL-cholesterolemia etc.), obesity (Body Mass Index: BMI ≥ 25), and/or a family history of diabetes (within a relation in the second degree)
[*] IGT is defined by WHO (World Health Organization) as “a state of higher than normal blood (or plasma) glucose concentration; fasting plasma glucose < 126 mg/dL and 2 hour post 75g oral glucose tolerance test of <6.9 mmol/L and 2-h OGTT 7.8 to 11.0mmol/L.” “75g oral glucose tolerance tests” determine whether a patient has diabetes by orally administering a dose 75g of glucose and determining their blood sugar before (= in a fasting state) and after the dosage.
SOURCE: Takeda |
