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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007024
Receipt No. 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

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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
Email

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
Email t.niiya@matsuyama-shimin-hsp.or.jp

Sponsor
Institute MATSUYAMA SHIMIN HOSPITAL
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008287

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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