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


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 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


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

Value
https://center6.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