UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002333 |
|---|---|
| Receipt number | 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 16:24:26 |
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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
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
Sponsor or person
Institute
Department of Medicine, Metabolism and Endocrinology
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002299
