>NEWSROOM >April - June 2008 >Voglibose (BASEN®) for the prevention of type 2 diabetes...

April - June 2008

Voglibose (BASEN®) for the prevention of type 2 diabetes mellitus:
A Randomized, Double-blind Trial in Japanese Subjects with Impaired Glucose Tolerance

--- Data Presented at The 51st Annual Meeting of the Japan Diabetes Society ---

May 26, 2008, Osaka, Japan --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that, on May 24 at the 51st Annual Meeting of the Japan Diabetes Society, the data from a phase 3 clinical study to evaluate the effects of BASEN® (generic name: voglibose) on prevention of onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (“IGT”) was presented. The data represents the first clinical evidence with Japanese subjects that showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy.

BASEN was launched in 1994 in Japan as an improving agent for postprandial hyperglycemia in diabetes mellitus. Based on the data presented this time, Takeda submitted on December 18, 2007 an application to the Ministry of Health, Labour and Welfare in Japan for an additional indication of “BASEN® Tablets 0.2” and “BASEN® OD Tablets 0.2” for prevention of onset of type 2 diabetes in patients with IGT.

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”. In the subjects with IGT, the risk of both the onset of type 2 diabetes and cardiovascular diseases is increased, and the dietary treatment and/or exercise therapy is conducted, however, there are cases in which sufficient effect has not been obtained. This phase 3 study conducted with BASEN was the first one with Japanese subjects to evaluate the preventive effect of the medicinal therapy for onset of type 2 diabetes though such clinical studies have been conducted with Western subjects.

“The number of patients with diabetes is notably increasing in Japan, and the necessity of managing diabetic complications is becoming an important social issue,” said Dr. Ryuzo Kawamori, Professor, Juntendo University Graduate School, who presented this data at the 51st Annual Meeting of the Japan Diabetes Society. “IGT increases a risk for onset of diabetes and cardiovascular diseases, and this data includes the first clinical evidence with Japanese subjects with IGT with risk factors such as hypertension and dyslipidemia, and showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy. It is meaningful to obtain this clinical evidence since BASEN, as an improving agent for postprandial hyperglycemia, is suitable for Japanese people whose IGT onset is mainly due to early stage insulin secretory deficiency.”

<Study Design>
A randomized, multi-centric (103 medical institutions), double-blind study
Population: subjects with IGT as defined by the WHO, who had at least one of the following risk factors;
  1. hypertension
  2. dyslipidemia
  3. obesity (BMI>=25)
  4. a family history of diabetes
Number of subjects: 1,778 consisting of two arms, one with voglibose (0.6mg, t.i.d.) and another with placebo (t.i.d.). Duration of treatment: medium 337 days under dietary treatment and/or exercise therapy
<Study Results>
Primary endpoint (Onset of type 2 diabetes)
placebo arm: 106 among 881 cases
voglibose arm: 50 among 897 cases
  (40.5% decrease, statistically significant difference, p=0.0014)
Secondary endpoint (Achivement of normalization of oral glucose tolerance test)
placebo arm: 454 among 881 cases
voglibose arm: 599 among 897 cases
  (53.9% increase, statistically significant difference, p<0.0001)
Safety

Adverse events such as diarrhea and flatulence were seen more frequently in voglibose arm than place arm. However, the overall safety profile shown in voglibose arm is comparable to the results which have been obtained with patients with diabetes, and no severe cases were found.

<About Basen® in Japan>
INDICATIONS

Improvement of postprandial hyperglycemia in diabetes mellitus. (However, BASEN® Tablets should be used only when sufficient effect has not been obtained in patients already undergoing dietary treatment and/or exercise therapy, or when sufficient effect has not been obtained in patients who have been using oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise therapy.)

DOSAGE AND ADMINISTRATION

Usually, for adults, BASEN® Tablets are orally administered in a single dose of 0.2 mg as voglibose, three times a day, just before each meal. If the effect is not sufficient enough, the single dose may be increased up to 0.3 mg, under close observation of the course of disease.

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