Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"
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|ClinicalTrials.gov Identifier: NCT01993927|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : November 2, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment|
|Impaired Glucose Tolerance||Drug: Voglibose|
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|
|Actual Enrollment :||742 participants|
|Official Title:||Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"|
|Actual Study Start Date :||November 18, 2009|
|Actual Primary Completion Date :||August 31, 2013|
|Actual Study Completion Date :||August 31, 2013|
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
- 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 [ Time Frame: Up to Week 72 ]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.
- Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period [ Time Frame: Up to Week 72 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993927
|Study Director:||Study Director||Takeda|