Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Basen Tablets 0.2 / Basen Oral Disintegrant（OD） Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"|
- Frequency of adverse events [ Time Frame: From baseline to Week 72 ]The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
- Progression to Type 2 Diabetes Mellitus (T2DM) [ Time Frame: From baseline to Week 72 ]Estimate over time of the cumulative rate of progression to T2DM. Diagnostic criteria for 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
- Normalization of Impaired Glucose Tolerance(IGT) [ Time Frame: From baseline to Week 72 ]Estimate over time of the cumulative rate of "IGT normalization". IGT normalization" will be determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.
|Study Start Date:||November 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Voglibose 0.2 mg or OD Tablets 0.2 mg
Voglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal.
Voglibose Tablets / Voglibose OD Tablets
Other Name: Basen Tablets, AO-128
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 patients with impaired glucose tolerance in the routine clinical setting.
Subjects 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01993927
|Study Chair:||Postmarketing Group Manager||Takeda|