UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007024 |
|---|---|
| Receipt number | R000008287 |
| Scientific Title | A open label, randomized, controled trial to assess the utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital. |
| Date of disclosure of the study information | 2012/01/06 |
| Last modified on | 2014/01/14 14:09:31 |
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Basic information
Public title
A open label, randomized, controled trial to assess the utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital.
Acronym
Utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital(POM study).
Scientific Title
A open label, randomized, controled trial to assess the utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital.
Scientific Title:Acronym
Utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital(POM study).
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with hyperlipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It aims at examining the improvement action and the mechanism of blood sugar or lipid by switch from atrovastatin to pitavastatin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change about HbA1c
Key secondary outcomes
1)change in following laboratory data
1.fasting Glucose
2.HOMA-IR
3.adiponectin
4.hs-CRP
5.visceral fat,hepatic CT
6.AST,ALT
7.serum lipids (TC,LDL-C,HDL-C,TG)
8.Apoprotein (ApoA-1,ApoB,ApoE)
2) Relationship of following laboratory data
1. Relationship of change about HbA1c and change about each laboratory data
2. Relationship BMI and change about each laboratory data
3. Relationship of change about serum lipids(LDL-C,HDL-C,TG),Apoprotein(ApoA-1,ApoB,ApoE)and change about each laboratory data
4. Relationship of change about ALT,AST and change about each laboratory data
5. Relationship of change about visceral fat,hepatic CT and change about each laboratory data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(Pitavastatin group)
Patients under treatment with pitavastatin (2mg/day) are switched from atrovastatin (10mg/day) to pitavastatin at the dose of 2mg/day for 6months.
Interventions/Control_2
(Atrovastatin group)
Patients under treatment with atrovastatin (10mg/day) group will continue therapy with atrovastatin at the dose of 10 mg/day for 6 months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been under treatment with atrovastatin for hyperlipidemia for more than 3 months.
2) Patients with type 2 diabetes mellitus.
3) Patients with HbA1c level 6.5-7.9%.
4) Patients with BMI level 25 or more.
Key exclusion criteria
1) Patients with insulin.
2) Patients requiring hospitalization to attain glycemic control.
3) Patients who have hypersensitivity to LIVALO tablet.
4) Patients who have severe liver dysfunction or biliary atresia.
5)Patients who are being treated with cyclosporine.
6) Pregnant women, women suspected of being pregnant, or lactating women.
7) Patients judged inadequate to participate in this study by their physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TETSUJI NIIYA |
Organization
MATSUYAMA SHIMIN HOSPITAL
Division name
Internal medicine
Zip code
Address
Ohtemachi 2-6-5, Matsuyama city, Ehime prefecture
TEL
089-943-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TETSUJI NIIYA |
Organization
MATSUYAMA SHIMIN HOSPITAL
Division name
Internal medicine
Zip code
Address
Ohtemachi 2-6-5, Matsuyama city, Ehime prefecture
TEL
089-943-1151
Homepage URL
t.niiya@matsuyama-shimin-hsp.or.jp
Sponsor or person
Institute
MATSUYAMA SHIMIN HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
松山市民病院(愛媛県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008287
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
