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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002333
Receipt No. R000002299
Scientific Title Additional effects of pioglitazone on type 2 diabetes who were inappropriately controled with
Date of disclosure of the study information 2009/08/15
Last modified on 2011/02/07

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Basic information
Public title Additional effects of pioglitazone on type 2 diabetes who were inappropriately controled with
Acronym ACTION-J
Scientific Title Additional effects of pioglitazone on type 2 diabetes who were inappropriately controled with
Scientific Title:Acronym ACTION-J
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether pioglitazone is effective (glycemic control and antiatherogenic effects) on type 2 diabetes patients who are under inappropriate glycemic control with insulin therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.HbA1C as glycemic control
2.Total daily dose and number of insulin
3.change of IMT
Key secondary outcomes frequency of hypoglycemic attack

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients were randomly divided into 2 groups (oral pioglitazone titrated from 15 mg to 30 mg or no pioglitazone, to be taken in addition to their glucose-lowering drugs and other medications) matched for age, gender, BMI, and baseline HbA1C after screen through the use of a computer-generated random number sequence. Patients were given recommendations for diet therapy during screening period and after randomization. No restriction was imposed on patients taking any oral diabetic agent except thiazolidinediones for control group and other oral drugs such as blood pressure-lowering and lipid-lowering drugs, and the dosage of the insulin and drugs can be changed freely by the physician's decision during the study.
Interventions/Control_2 any drugs other than pioglitazone are allowed to be used.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria type 2 diabetes patients insulin therpy under inappropriate glycemic control.
1.the patients who get imformed consent with written paper.
2. the patients whose HbA1c has been more than 7.0% for more than 1 year
Key exclusion criteria 1.the patients who had CVD or appoplexy within 6 months
2. the patients who have had hear failure (NYHA >III)
3. severe hepatic or renal failure
4. the patients who have had diabetic ketoacidosis
5. pregnant women
6. the pateints who has history of severe adverse effects with pioglitazone
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose
Organization Juntendo University School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Medicine, Metabolism and Endocrinology
Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Industory
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2009 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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
2007 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 13 Day
Last modified on
2011 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002299

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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