Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance Long-term Use in Patients With Impaired Glucose Tolerance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance Long-term Use in Patients With Impaired Glucose Tolerance

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: Voglibose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet all of the following criteria ([1] to [3]) to be included in this study: Determined as having IGT (defined as fasting blood glucose < 126 mg/dL and 2-hour post 75-g oral glucose tolerance test [OGTT] blood glucose of 140-199 mg/dL) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months Meets any of the following conditions: (i) Concurrently has hypertension*1 (ii) Concurrently has dyslipidemia*2 (iii) Is obese (BMI ≥25 kg/m^2) (iv) Has a family history of diabetes mellitus in relatives to the second degree as defined by Japanese law*3 Regularly visits the study site and can be observed for 72 weeks 1: Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication. 2: Dyslipidaemia: Participants with any of the following conditions or participants on oral antidyslipidemic medication Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL) Hypo HDL cholesterolemia (fasting HDL-cholesterol < 40 mg/dL) Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) *3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren. Note that these do not include spouse's relatives. Exclusion Criteria: Participants meeting either of the following criteria ([1] or [2]) will be excluded: Previously diagnosed with diabetes mellitus Has any contraindications to Basen as specified below: (i) Severe ketosis, diabetic coma or precoma (ii) Severe infection, perioperative state, or serious trauma (iii) History of hypersensitivity to any ingredients of Basen
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Voglibose 0.2 mg or OD Tablets 0.2 mg<br>Voglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal. | Drug: Voglibose<br>* Voglibose Tablets / Voglibose OD Tablets<br>* Other names: Basen Tablets, AO-128;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Events |  | 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. | Up to Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy