The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.
This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting. Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000. The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.
Study Type
OBSERVATIONAL
Enrollment
742
Voglibose Tablets / Voglibose OD Tablets
Unnamed facility
Osaka, Japan
Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to Week 72
Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
Percentage of participants who occurred progression of T2DM during treatment period was reported. Diagnostic criteria for progression of T2DM are: (1) "Blood glucose ≥200 mg/dL at any time, morning fasting blood glucose ≥126 mg/dL, or 2-hour post 75-g (Oral Glucose Tolerance Test) blood glucose ≥200 mg/dL. (2) Two or more glucose measurements obtained on different days that meet the above-mentioned criteria, or (3) A single glucose measurement meeting the above-mentioned criteria if the patient meets any of the following conditions: (i) Has typical symptoms of diabetes mellitus (e.g., dry mouth, polydipsia, polyuria, weight loss) (ii) HbA1C ≥6.5% (JDS value) (iii) Obvious diabetic retinopathy.
Time frame: Up to Week 72
Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
Percentage of participants who had normalization of Impaired Glucose Tolerance (IGT) during treatment period was reported. IGT normalization was determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.
Time frame: Up to Week 72
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