UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001109 |
|---|---|
| Receipt number | R000001296 |
| Scientific Title | A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus (Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison) |
| Date of disclosure of the study information | 2008/04/07 |
| Last modified on | 2010/08/27 17:11:31 |
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Basic information
Public title
A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus
(Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)
Acronym
A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of Voglibose on prevention of type 2 diabetes mellitus
(Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)
Scientific Title
A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus
(Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)
Scientific Title:Acronym
A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of Voglibose on prevention of type 2 diabetes mellitus
(Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)
Region
| Japan |
Condition
Condition
Impaired glucose tolerance (IGT)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical study is to evaluate the effects of AO-128 compared to placebo on prevention of onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (IGT)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression from IGT to type 2 diabetes mellitus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
AO-128 (Voglibose) 0.2mg tab. tid
At least 144 weeks, or by progression type 2 diabetes or improvement to normal OGTT
Interventions/Control_2
Placebo tab. tid
At least 144 weeks, or by progression type 2 diabetes or improvement to normal OGTT
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Fasting plasma/serum glucose level: <125mg/dL and 2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL in a 75g oral glucose tolerance test
2. HbA1c:<6.5%
Key exclusion criteria
1. Patient has a history of diabetes mellitus
2. Patient with serious hepatic or renal disorders
Target sample size
1782
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuzo Kawamori |
Organization
Juntendo University, school of medicine
Division name
Department of Medicine, Metabolism and Endocrinology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku,Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Takeda Pharmaceutical Company Limited
Division name
Contact for Clinical Trial Information
Zip code
Address
TEL
Homepage URL
https://www.takeda.co.jp/contact/form/jp/form/
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.takeda.com/c-t/report-summaries/article_53.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 04 | Day |
Last modified on
| 2010 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001296
