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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001109
Receipt No. 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

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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
Email

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/
Email

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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