Impaired Glucose Tolerance
Conditions
Keywords
Drug Therapy
Brief summary
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
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.
Interventions
DRUGVoglibose
Voglibose Tablets / Voglibose OD Tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants must meet all of the following criteria (\[1\] to \[3\]) to be included in this study: 1. 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 2. 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 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: 1. Previously diagnosed with diabetes mellitus 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 130 investigative sites in Japan, from 18-November-2009 to 31-August-2013.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 713 |
| Total | 713 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 18 |
| Overall Study | Protocol Violation | 11 |
Baseline characteristics
| Characteristic | Voglibose 0.2 mg or OD Tablets 0.2 mg |
|---|---|
| 75g OGTT Blood Glucose Level at 2 hr after Dosing | 168.2 mg/dL STANDARD_DEVIATION 17.42 |
| 75g OGTT Blood Glucose Level at 30 min after Dosing | 181.4 mg/dL STANDARD_DEVIATION 28.45 |
| 75g OGTT Fasting Blood Glucose Level | 105.3 mg/dL STANDARD_DEVIATION 11 |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 11.86 |
| Blood Insulin Level at 2 hr after Dosing | 69.405 mcU/mL STANDARD_DEVIATION 52.2083 |
| Blood Insulin Level at 30 min after Dosing | 38.122 mcU/mL STANDARD_DEVIATION 25.7354 |
| BMI | 24.55 kg/m^2 STANDARD_DEVIATION 3.873 |
| Compliance of Dietary Therapy at 3 Months prior to Study Start Compliance level of < 70% | 212 Participants |
| Compliance of Dietary Therapy at 3 Months prior to Study Start Compliance level of ≥ 70% | 297 Participants |
| Compliance of Dietary Therapy at 3 Months prior to Study Start Unknown | 204 Participants |
| Compliance of Dietary Therapy at 6 Months prior to Study Start Compliance level of < 70% | 107 Participants |
| Compliance of Dietary Therapy at 6 Months prior to Study Start Compliance level of ≥ 70% | 187 Participants |
| Compliance of Dietary Therapy at 6 Months prior to Study Start Unknown | 419 Participants |
| Compliance of Dietary Therapy at Treatment Start Compliance level of < 70% | 240 Participants |
| Compliance of Dietary Therapy at Treatment Start Compliance level of ≥ 70% | 391 Participants |
| Compliance of Dietary Therapy at Treatment Start Unknown | 82 Participants |
| Compliance of Exercise Therapy at 3 Months prior to Study Start Compliance level of < 70% | 221 Participants |
| Compliance of Exercise Therapy at 3 Months prior to Study Start Compliance level of ≥ 70% | 260 Participants |
| Compliance of Exercise Therapy at 3 Months prior to Study Start Unknown | 232 Participants |
| Compliance of Exercise Therapy at 6 Months prior to Study Start Compliance level of < 70% | 120 Participants |
| Compliance of Exercise Therapy at 6 Months prior to Study Start Compliance level of ≥ 70% | 167 Participants |
| Compliance of Exercise Therapy at 6 Months prior to Study Start Unknown | 426 Participants |
| Compliance of Exercise Therapy at Treatment Start Compliance level of < 70% | 269 Participants |
| Compliance of Exercise Therapy at Treatment Start Compliance level of ≥ 70% | 331 Participants |
| Compliance of Exercise Therapy at Treatment Start Unknown | 113 Participants |
| Daily Activity Intensity Index III (moderate/optimal) | 245 Participants |
| Daily Activity Intensity Index II (mild activities) | 302 Participants |
| Daily Activity Intensity Index I (very mild activities in a day) | 159 Participants |
| Daily Activity Intensity Index IV (very strong activities in a day) | 7 Participants |
| Drinking Habits Current Drinker | 261 Participants |
| Drinking Habits Ex-Drinker | 47 Participants |
| Drinking Habits Never Drank | 404 Participants |
| Drinking Habits Unknown | 1 Participants |
| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose ≥ 1 year | 14 Participants |
| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose < 3 months | 304 Participants |
| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose ≥ 3 months < 6 months | 176 Participants |
| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose ≥ 6 months < 1 year | 163 Participants |
| Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose Not performed | 56 Participants |
| Duration of Disease | 12.51 Months STANDARD_DEVIATION 23.708 |
| Family History of Diabetes in Second-Degree Relatives Had Family History of Diabetes | 146 Participants |
| Family History of Diabetes in Second-Degree Relatives Had No Family History of Diabetes | 567 Participants |
| Fasting Blood Insulin Level | 7.311 mcU/mL STANDARD_DEVIATION 4.872 |
| HbA1c (Japan DiabetesSociety; JDS Value) | 5.72 Percent STANDARD_DEVIATION 0.399 |
| HbA1c (National Glycohemoglobin Standardization Program; NGSP Value) | 6.11 Percent STANDARD_DEVIATION 0.406 |
| Healthcare Category Inpatient | 2 Participants |
| Healthcare Category Inpatient and Outpatient | 5 Participants |
| Healthcare Category Outpatient | 706 Participants |
| Height | 160.21 cm STANDARD_DEVIATION 9.619 |
| History of Allergy Had History of Allergy | 59 Participants |
| History of Allergy Had No History of Allergy | 623 Participants |
| History of Allergy Unknown | 31 Participants |
| History of Obesity Had History of Obesity | 303 Participants |
| History of Obesity Had No History of Obesity | 410 Participants |
| Homeostasis Model Assessment of Insulin Resistance | 1.913 Percent score of insulin resistance STANDARD_DEVIATION 1.3331 |
| Insulinogenic Index | 0.449 Score of insulinogenic Index STANDARD_DEVIATION 0.3914 |
| Medical Complications Had No Presence of Medical Complications | 46 Participants |
| Medical Complications Had Presence of Medical Complications | 667 Participants |
| Medical History Had No Presence of Medical History | 584 Participants |
| Medical History Had Presence of Medical History | 126 Participants |
| Medical History Unknown | 3 Participants |
| Number of Risk Factor Five Factors | 19 Participants |
| Number of Risk Factor Four Factors | 178 Participants |
| Number of Risk Factor None | 0 Participants |
| Number of Risk Factor One Factor | 0 Participants |
| Number of Risk Factor Three Factors | 278 Participants |
| Number of Risk Factor Two Factors | 238 Participants |
| Pregnancy Status Not pregnant | 337 Participants |
| Pregnancy Status Pregnant | 0 Participants |
| Region of Enrollment Japan | 713 Participants |
| Sex: Female, Male Female | 337 Participants |
| Sex: Female, Male Male | 376 Participants |
| Smoking Classification Current Smoker | 92 Participants |
| Smoking Classification Ex-Smoker | 87 Participants |
| Smoking Classification Never Smoked | 533 Participants |
| Smoking Classification Unknown | 1 Participants |
| Weight | 63.21 kg STANDARD_DEVIATION 13.097 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 713 |
| serious Total, serious adverse events | 5 / 713 |
Outcome results
Primary
Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to Week 72
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Voglibose 0.2 mg or OD Tablets 0.2 mg | Number of Participants Who Experience at Least One Adverse Events | 88 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.
Time frame: Up to Week 72
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voglibose 0.2 mg or OD Tablets 0.2 mg | Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period | 4.8 Percentage of participants |
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.
Time frame: Up to Week 72
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voglibose 0.2 mg or OD Tablets 0.2 mg | Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period | 11.3 Percentage of participants |