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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Impaired Glucose Tolerance
Intervention Drug: Voglibose
Enrollment 742
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).
Arm/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 742
Completed 713
Not Completed 29
Reason Not Completed
Case Report Forms Uncollected             18
Protocol Violation             11
Arm/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 713
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 713 participants
62.6  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 713 participants
Female
337
  47.3%
Male
376
  52.7%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 713 participants
713
[1]
Measure Description: All participants were enrolled in Japan.
Duration of Disease   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 713 participants
12.51  (23.708)
[1]
Measure Description: Mean Duration between start of study and first time of diagnosis of Impaired Glucose Tolerance (IGT) was reported.
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Outpatient Number Analyzed 713 participants
706
  99.0%
Inpatient Number Analyzed 713 participants
2
   0.3%
Inpatient and Outpatient Number Analyzed 713 participants
5
   0.7%
[1]
Measure Description: 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).
Pregnancy Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Not pregnant Number Analyzed 337 participants
337
 100.0%
Pregnant Number Analyzed 337 participants
0
   0.0%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
History of Allergy  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No History of Allergy Number Analyzed 713 participants
623
  87.4%
Had History of Allergy Number Analyzed 713 participants
59
   8.3%
Unknown Number Analyzed 713 participants
31
   4.3%
Family History of Diabetes in Second-Degree Relatives  
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Family History of Diabetes Number Analyzed 713 participants
567
  79.5%
Had Family History of Diabetes Number Analyzed 713 participants
146
  20.5%
History of Obesity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Had No History of Obesity Number Analyzed 713 participants
410
  57.5%
Had History of Obesity Number Analyzed 713 participants
303
  42.5%
[1]
Measure Description: Number of Participants with 25 kg/m^2 or more as Body Mass Index were reported.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Presence of Medical Complications Number Analyzed 713 participants
46
   6.5%
Had Presence of Medical Complications Number Analyzed 713 participants
667
  93.5%
[1]
Measure Description: 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.
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Had No Presence of Medical History Number Analyzed 713 participants
584
  81.9%
Had Presence of Medical History Number Analyzed 713 participants
126
  17.7%
Unknown Number Analyzed 713 participants
3
   0.4%
[1]
Measure Description: 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.
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 713 participants
160.21  (9.619)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 713 participants
63.21  (13.097)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 713 participants
24.55  (3.873)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Drinking Habits  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Drank Number Analyzed 713 participants
404
  56.7%
Ex-Drinker Number Analyzed 713 participants
47
   6.6%
Current Drinker Number Analyzed 713 participants
261
  36.6%
Unknown Number Analyzed 713 participants
1
   0.1%
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Smoked Number Analyzed 713 participants
533
  74.8%
Ex-Smoker Number Analyzed 713 participants
87
  12.2%
Current Smoker Number Analyzed 713 participants
92
  12.9%
Unknown Number Analyzed 713 participants
1
   0.1%
Duration of Dietary and Exercise Therapies prior to the Administration of Voglibose  
Measure Type: Count of Participants
Unit of measure:  Participants
Not performed Number Analyzed 713 participants
56
   7.9%
< 3 months Number Analyzed 713 participants
304
  42.6%
≥ 3 months < 6 months Number Analyzed 713 participants
176
  24.7%
≥ 6 months < 1 year Number Analyzed 713 participants
163
  22.9%
≥ 1 year Number Analyzed 713 participants
14
   2.0%
Daily Activity Intensity Index   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
I (very mild activities in a day) Number Analyzed 713 participants
159
  22.3%
II (mild activities) Number Analyzed 713 participants
302
  42.4%
III (moderate/optimal) Number Analyzed 713 participants
245
  34.4%
IV (very strong activities in a day) Number Analyzed 713 participants
7
   1.0%
[1]
Measure Description: 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.
75g OGTT Fasting Blood Glucose Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 713 participants
105.3  (11.00)
[1]
Measure Description: 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.
75g OGTT Blood Glucose Level at 30 min after Dosing  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 713 participants
181.4  (28.45)
75g OGTT Blood Glucose Level at 2 hr after Dosing  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 713 participants
168.2  (17.42)
Fasting Blood Insulin Level  
Mean (Standard Deviation)
Unit of measure:  mcU/mL
Number Analyzed 713 participants
7.311  (4.8720)
Blood Insulin Level at 30 min after Dosing  
Mean (Standard Deviation)
Unit of measure:  mcU/mL
Number Analyzed 713 participants
38.122  (25.7354)
Blood Insulin Level at 2 hr after Dosing  
Mean (Standard Deviation)
Unit of measure:  mcU/mL
Number Analyzed 713 participants
69.405  (52.2083)
HbA1c (Japan DiabetesSociety; JDS Value)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 713 participants
5.72  (0.399)
[1]
Measure Description: 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%.
HbA1c (National Glycohemoglobin Standardization Program; NGSP Value)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 713 participants
6.11  (0.406)
[1]
Measure Description: 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%.
Homeostasis Model Assessment of Insulin Resistance   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent score of insulin resistance
Number Analyzed 713 participants
1.913  (1.3331)
[1]
Measure Description: Homeostasis Model assessment of insulin resistance measures insulin resistance, calculated by fasting insulin times fasting glucose, divided by a constant (405).
Insulinogenic Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Score of insulinogenic Index
Number Analyzed 713 participants
0.449  (0.3914)
[1]
Measure Description: 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).
Number of Risk Factor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
None Number Analyzed 713 participants
0
   0.0%
One Factor Number Analyzed 713 participants
0
   0.0%
Two Factors Number Analyzed 713 participants
238
  33.4%
Three Factors Number Analyzed 713 participants
278
  39.0%
Four Factors Number Analyzed 713 participants
178
  25.0%
Five Factors Number Analyzed 713 participants
19
   2.7%
[1]
Measure Description: 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
Compliance of Dietary Therapy at 6 Months prior to Study Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
187
  26.2%
Compliance level of < 70% Number Analyzed 713 participants
107
  15.0%
Unknown Number Analyzed 713 participants
419
  58.8%
Compliance of Dietary Therapy at 3 Months prior to Study Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
297
  41.7%
Compliance level of < 70% Number Analyzed 713 participants
212
  29.7%
Unknown Number Analyzed 713 participants
204
  28.6%
Compliance of Dietary Therapy at Treatment Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
391
  54.8%
Compliance level of < 70% Number Analyzed 713 participants
240
  33.7%
Unknown Number Analyzed 713 participants
82
  11.5%
Compliance of Exercise Therapy at 6 Months prior to Study Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
167
  23.4%
Compliance level of < 70% Number Analyzed 713 participants
120
  16.8%
Unknown Number Analyzed 713 participants
426
  59.7%
Compliance of Exercise Therapy at 3 Months prior to Study Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
260
  36.5%
Compliance level of < 70% Number Analyzed 713 participants
221
  31.0%
Unknown Number Analyzed 713 participants
232
  32.5%
Compliance of Exercise Therapy at Treatment Start  
Measure Type: Count of Participants
Unit of measure:  Participants
Compliance level of ≥ 70% Number Analyzed 713 participants
331
  46.4%
Compliance level of < 70% Number Analyzed 713 participants
269
  37.7%
Unknown Number Analyzed 713 participants
113
  15.8%
1.Primary Outcome
Title Number of Participants Who Experience at Least One Adverse Events
Hide Description [Not Specified]
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 713
Measure Type: Count of Participants
Unit of Measure: Participants
88
  12.3%
2.Primary Outcome
Title Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 708
Measure Type: Number
Unit of Measure: Percentage of participants
4.8
3.Secondary Outcome
Title Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 708
Measure Type: Number
Unit of Measure: Percentage of participants
11.3
Time Frame Baseline up to Week 72
Adverse Event Reporting Description 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.
 
Arm/Group Title Voglibose 0.2 mg or OD Tablets 0.2 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Voglibose 0.2 mg or OD Tablets 0.2 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Voglibose 0.2 mg or OD Tablets 0.2 mg
Affected / at Risk (%)
Total   5/713 (0.70%) 
Blood and lymphatic system disorders   
Thrombocytopenic purpura  1  1/713 (0.14%) 
Cardiac disorders   
Angina pectoris  1  1/713 (0.14%) 
Endocrine disorders   
Eye disorders  1  1/713 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant  1  1/713 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/713 (0.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Voglibose 0.2 mg or OD Tablets 0.2 mg
Affected / at Risk (%)
Total   39/713 (5.47%) 
Gastrointestinal disorders   
Diarrhoea  1  14/713 (1.96%) 
Abdominal distension  1  14/713 (1.96%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  11/713 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01993927     History of Changes
Other Study ID Numbers: 340-012
JapicCTI-132304 ( Registry Identifier: JapicCTI )
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: August 2, 2017
Results First Posted: November 2, 2018
Last Update Posted: December 4, 2018