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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132304 | Registry Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voglibose | Drug | Voglibose Tablets / Voglibose OD Tablets |
|
| 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 |
| 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. |
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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
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
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Participants with impaired glucose tolerance
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan |
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Participants, who had determined as having impaired glucose tolerance (IGT) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months, were enrolled to receive voglibose 0.2 milligram (mg) orally, three times daily, up to 72 months (approximately 1 year and 6 months).
Participants took part in the study at 130 investigative sites in Japan, from 18-November-2009 to 31-August-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Voglibose 0.2 mg or OD Tablets 0.2 mg | Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. All data could be received as case report forms without major protocol violations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Voglibose 0.2 mg or OD Tablets 0.2 mg | Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Events | Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. All data could be received as case report forms without major protocol violations. | Posted | Count of Participants | Participants | Up to Week 72 |
|
|
Baseline up to Week 72
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Participants may be represented in more than 1 category.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voglibose 0.2 mg or OD Tablets 0.2 mg | Voglibose 0.2 mg or OD Tablets 0.2 mg was administered orally three times daily immediately before each meal, up to 72 months (approximately 1 year and 6 months). Participants will receive interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C102817 | voglibose |
| C054577 | AO 128 |
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| Up to Week 72 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
|
| Duration of Disease | Mean Duration between start of study and first time of diagnosis of Impaired Glucose Tolerance (IGT) was reported. | Mean | Standard Deviation | Months |
|
| Healthcare Category | Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment). | Count of Participants | Participants |
|
| Pregnancy Status | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
| History of Allergy | Count of Participants | Participants |
|
| Family History of Diabetes in Second-Degree Relatives | Count of Participants | Participants |
|
| History of Obesity | Number of Participants with 25 kg/m^2 or more as Body Mass Index were reported. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
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| Drinking Habits | Count of Participants | Participants |
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| Smoking Classification | Count of Participants | Participants |
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| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose | Count of Participants | Participants |
|
| Daily Activity Intensity Index | Daily Activity Intensity Index is scored time in a day checked by investigators, assessing intensity of daily-life activities including five sub-scales which are Laying, Standing, Walking, Running and Exercising. Score range is from 1 (very mild activities in a day) to 4 (very strong activities in a day). Higher scores reflect stronger activities of participants in a day. | Count of Participants | Participants |
|
| 75g OGTT Fasting Blood Glucose Level | OGTT; Oral glucose tolerance test. 75 g Oral glucose tolerance test measures blood glucose through blood samples drawn at 30, 60, 120 minutes following consumption of a 75 g glucose beverage. | Mean | Standard Deviation | mg/dL |
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| 75g OGTT Blood Glucose Level at 30 min after Dosing | Mean | Standard Deviation | mg/dL |
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| 75g OGTT Blood Glucose Level at 2 hr after Dosing | Mean | Standard Deviation | mg/dL |
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| Fasting Blood Insulin Level | Mean | Standard Deviation | mcU/mL |
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| Blood Insulin Level at 30 min after Dosing | Mean | Standard Deviation | mcU/mL |
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| Blood Insulin Level at 2 hr after Dosing | Mean | Standard Deviation | mcU/mL |
|
| HbA1c (Japan DiabetesSociety; JDS Value) | HbA1c (JDS) shows a concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The 6.5% HbA1c is the JDS value, and is equivalent to the NGSP HbA1c value of 6.9%. | Mean | Standard Deviation | Percent |
|
| HbA1c (National Glycohemoglobin Standardization Program; NGSP Value) | HbA1c (NGSP) shows a concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The 6.5% HbA1c is the JDS value, and is equivalent to the NGSP HbA1c value of 6.9%. | Mean | Standard Deviation | Percent |
|
| Homeostasis Model Assessment of Insulin Resistance | Homeostasis Model assessment of insulin resistance measures insulin resistance, calculated by fasting insulin times fasting glucose, divided by a constant (405). | Mean | Standard Deviation | Percent score of insulin resistance |
|
| Insulinogenic Index | Insulinogenic Index measures secretion of insulin, calculated by change from baseline in measured blood insulin at 30min (mcrU/ml), divided by change from baseline in measured blood glucose at 30min (mg/dl). | Mean | Standard Deviation | Score of insulinogenic Index |
|
| Number of Risk Factor | Reporting number of factors of risk which each participant had at study start. Factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, Family History of Diabetes in Second-Degree Relatives | Count of Participants | Participants |
|
| Compliance of Dietary Therapy at 6 Months prior to Study Start | Count of Participants | Participants |
|
| Compliance of Dietary Therapy at 3 Months prior to Study Start | Count of Participants | Participants |
|
| Compliance of Dietary Therapy at Treatment Start | Count of Participants | Participants |
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| Compliance of Exercise Therapy at 6 Months prior to Study Start | Count of Participants | Participants |
|
| Compliance of Exercise Therapy at 3 Months prior to Study Start | Count of Participants | Participants |
|
| Compliance of Exercise Therapy at Treatment Start | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. Reported data was collected from received case report forms including the data, without major protocol violations. | Posted | Number | Percentage of participants | Up to Week 72 |
|
|
|
| Secondary | 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. | Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. Reported data was collected from received case report forms including the data, without major protocol violations. | Posted | Number | Percentage of participants | Up to Week 72 |
|
|
|
| 5 |
| 713 |
| 39 |
| 713 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Eye disorders | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.