Trial Outcomes & Findings for Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance" (NCT NCT01993927)
NCT ID: NCT01993927
Last Updated: 2018-12-04
Results Overview
Recruitment status
COMPLETED
Target enrollment
742 participants
Primary outcome timeframe
Up to Week 72
Results posted on
2018-12-04
Participant Flow
Participants took part in the study at 130 investigative sites in Japan, from 18-November-2009 to 31-August-2013.
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).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
742
|
|
Overall Study
COMPLETED
|
713
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Case Report Forms Uncollected
|
18
|
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Overall Study
Protocol Violation
|
11
|
Baseline Characteristics
This baseline characteristic was analyzed only in female participants.
Baseline characteristics by cohort
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=713 Participants
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.
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 11.86 • n=713 Participants
|
|
Sex: Female, Male
Female
|
337 Participants
n=713 Participants
|
|
Sex: Female, Male
Male
|
376 Participants
n=713 Participants
|
|
Region of Enrollment
Japan
|
713 Participants
n=713 Participants
|
|
Duration of Disease
|
12.51 Months
STANDARD_DEVIATION 23.708 • n=713 Participants
|
|
Healthcare Category
Outpatient
|
706 Participants
n=713 Participants
|
|
Healthcare Category
Inpatient
|
2 Participants
n=713 Participants
|
|
Healthcare Category
Inpatient and Outpatient
|
5 Participants
n=713 Participants
|
|
Pregnancy Status
Not pregnant
|
337 Participants
n=337 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Pregnancy Status
Pregnant
|
0 Participants
n=337 Participants • This baseline characteristic was analyzed only in female participants.
|
|
History of Allergy
Had No History of Allergy
|
623 Participants
n=713 Participants
|
|
History of Allergy
Had History of Allergy
|
59 Participants
n=713 Participants
|
|
History of Allergy
Unknown
|
31 Participants
n=713 Participants
|
|
Family History of Diabetes in Second-Degree Relatives
Had No Family History of Diabetes
|
567 Participants
n=713 Participants
|
|
Family History of Diabetes in Second-Degree Relatives
Had Family History of Diabetes
|
146 Participants
n=713 Participants
|
|
History of Obesity
Had No History of Obesity
|
410 Participants
n=713 Participants
|
|
History of Obesity
Had History of Obesity
|
303 Participants
n=713 Participants
|
|
Medical Complications
Had No Presence of Medical Complications
|
46 Participants
n=713 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
667 Participants
n=713 Participants
|
|
Medical History
Had No Presence of Medical History
|
584 Participants
n=713 Participants
|
|
Medical History
Had Presence of Medical History
|
126 Participants
n=713 Participants
|
|
Medical History
Unknown
|
3 Participants
n=713 Participants
|
|
Height
|
160.21 cm
STANDARD_DEVIATION 9.619 • n=713 Participants
|
|
Weight
|
63.21 kg
STANDARD_DEVIATION 13.097 • n=713 Participants
|
|
BMI
|
24.55 kg/m^2
STANDARD_DEVIATION 3.873 • n=713 Participants
|
|
Drinking Habits
Never Drank
|
404 Participants
n=713 Participants
|
|
Drinking Habits
Ex-Drinker
|
47 Participants
n=713 Participants
|
|
Drinking Habits
Current Drinker
|
261 Participants
n=713 Participants
|
|
Drinking Habits
Unknown
|
1 Participants
n=713 Participants
|
|
Smoking Classification
Never Smoked
|
533 Participants
n=713 Participants
|
|
Smoking Classification
Ex-Smoker
|
87 Participants
n=713 Participants
|
|
Smoking Classification
Current Smoker
|
92 Participants
n=713 Participants
|
|
Smoking Classification
Unknown
|
1 Participants
n=713 Participants
|
|
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose
Not performed
|
56 Participants
n=713 Participants
|
|
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose
< 3 months
|
304 Participants
n=713 Participants
|
|
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose
≥ 3 months < 6 months
|
176 Participants
n=713 Participants
|
|
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose
≥ 6 months < 1 year
|
163 Participants
n=713 Participants
|
|
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose
≥ 1 year
|
14 Participants
n=713 Participants
|
|
Daily Activity Intensity Index
I (very mild activities in a day)
|
159 Participants
n=713 Participants
|
|
Daily Activity Intensity Index
II (mild activities)
|
302 Participants
n=713 Participants
|
|
Daily Activity Intensity Index
III (moderate/optimal)
|
245 Participants
n=713 Participants
|
|
Daily Activity Intensity Index
IV (very strong activities in a day)
|
7 Participants
n=713 Participants
|
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75g OGTT Fasting Blood Glucose Level
|
105.3 mg/dL
STANDARD_DEVIATION 11.00 • n=713 Participants
|
|
75g OGTT Blood Glucose Level at 30 min after Dosing
|
181.4 mg/dL
STANDARD_DEVIATION 28.45 • n=713 Participants
|
|
75g OGTT Blood Glucose Level at 2 hr after Dosing
|
168.2 mg/dL
STANDARD_DEVIATION 17.42 • n=713 Participants
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Fasting Blood Insulin Level
|
7.311 mcU/mL
STANDARD_DEVIATION 4.8720 • n=713 Participants
|
|
Blood Insulin Level at 30 min after Dosing
|
38.122 mcU/mL
STANDARD_DEVIATION 25.7354 • n=713 Participants
|
|
Blood Insulin Level at 2 hr after Dosing
|
69.405 mcU/mL
STANDARD_DEVIATION 52.2083 • n=713 Participants
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HbA1c (Japan DiabetesSociety; JDS Value)
|
5.72 Percent
STANDARD_DEVIATION 0.399 • n=713 Participants
|
|
HbA1c (National Glycohemoglobin Standardization Program; NGSP Value)
|
6.11 Percent
STANDARD_DEVIATION 0.406 • n=713 Participants
|
|
Homeostasis Model Assessment of Insulin Resistance
|
1.913 Percent score of insulin resistance
STANDARD_DEVIATION 1.3331 • n=713 Participants
|
|
Insulinogenic Index
|
0.449 Score of insulinogenic Index
STANDARD_DEVIATION 0.3914 • n=713 Participants
|
|
Number of Risk Factor
None
|
0 Participants
n=713 Participants
|
|
Number of Risk Factor
One Factor
|
0 Participants
n=713 Participants
|
|
Number of Risk Factor
Two Factors
|
238 Participants
n=713 Participants
|
|
Number of Risk Factor
Three Factors
|
278 Participants
n=713 Participants
|
|
Number of Risk Factor
Four Factors
|
178 Participants
n=713 Participants
|
|
Number of Risk Factor
Five Factors
|
19 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 6 Months prior to Study Start
Compliance level of ≥ 70%
|
187 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 6 Months prior to Study Start
Compliance level of < 70%
|
107 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 6 Months prior to Study Start
Unknown
|
419 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 3 Months prior to Study Start
Compliance level of ≥ 70%
|
297 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 3 Months prior to Study Start
Compliance level of < 70%
|
212 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at 3 Months prior to Study Start
Unknown
|
204 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at Treatment Start
Compliance level of ≥ 70%
|
391 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at Treatment Start
Compliance level of < 70%
|
240 Participants
n=713 Participants
|
|
Compliance of Dietary Therapy at Treatment Start
Unknown
|
82 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 6 Months prior to Study Start
Compliance level of ≥ 70%
|
167 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 6 Months prior to Study Start
Compliance level of < 70%
|
120 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 6 Months prior to Study Start
Unknown
|
426 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 3 Months prior to Study Start
Compliance level of ≥ 70%
|
260 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 3 Months prior to Study Start
Compliance level of < 70%
|
221 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at 3 Months prior to Study Start
Unknown
|
232 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at Treatment Start
Compliance level of ≥ 70%
|
331 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at Treatment Start
Compliance level of < 70%
|
269 Participants
n=713 Participants
|
|
Compliance of Exercise Therapy at Treatment Start
Unknown
|
113 Participants
n=713 Participants
|
PRIMARY outcome
Timeframe: Up to Week 72Population: 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.
Outcome measures
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=713 Participants
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.
|
|---|---|
|
Number of Participants Who Experience at Least One Adverse Events
|
88 Participants
|
PRIMARY outcome
Timeframe: Up to Week 72Population: 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.
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.
Outcome measures
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=708 Participants
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.
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|---|---|
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Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
|
4.8 Percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 72Population: 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.
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.
Outcome measures
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=708 Participants
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.
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|---|---|
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Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
|
11.3 Percentage of participants
|
Adverse Events
Voglibose 0.2 mg or OD Tablets 0.2 mg
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=713 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.14%
1/713 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.14%
1/713 • 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.
|
|
Cardiac disorders
Angina pectoris
|
0.14%
1/713 • 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.
|
|
Endocrine disorders
Eye disorders
|
0.14%
1/713 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.14%
1/713 • 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.
|
Other adverse events
| Measure |
Voglibose 0.2 mg or OD Tablets 0.2 mg
n=713 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
14/713 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
14/713 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.5%
11/713 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER