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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002318
Receipt No. R000002827
Scientific Title Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation
Date of disclosure of the study information 2009/08/11
Last modified on 2010/04/06

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Basic information
Public title Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation
Acronym Ezetimibe/statin combination therapy in patients with type 2 diabetes
Scientific Title Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation
Scientific Title:Acronym Ezetimibe/statin combination therapy in patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect of ezetimibe on the serum levels of RLP-cholesterol and inflammation markers in type 2 diabetic patients with hypercholesterolemia who have been treated with statins.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change of the serum levels of RLP- Cholesterol (4 months after initiaion of therapy)
Key secondary outcomes Change of the serum levels of the following serum inflammatory markers and lipids(4 months after initiaion of therapy)

1)hsCRP, 2)IL-6, 3)IL-18, 4)apoB48, 5)total cholesterol, 6)LDL cholesterol, 7)HDL cholesterol, 8)triglyceride, 9)adiponectin, 10)TNFa, 11)insulin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ezetimibe (10mg) daily, for 4 months
Interventions/Control_2
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 Patients who meet all of the following criteria:

1) Patients with type 2 diabetes over 20 yeras old

2)Patients who have been treated with statins for more than 3 months

3)Patients whose serum LDL cholesterol levels do not reach the control target values of Japan Atherosclerosis Society Guideline 2007.
Key exclusion criteria 1)During pregnancy or lactation
2)Patients who had allergy to ezetimibe
3)Serious liver or renal diseases
4)Acute or chronic inflammatory diseases
5)Other conditions precluding participation as judged by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Ogawa
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, chuo-ku, Kobe
TEL 078-382-5861
Email

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Ogawa
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, chuo-ku, Kobe
TEL 078-382-5861
Homepage URL
Email

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Rokko Island Hspital, Konan Hospital, Shin-Suma Hospital, Obara Hospital, Sugano Clinic, Ooshiro Clinic, Amano Clinic, Osaka Koseinenkin Hospital
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 11 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
Date of protocol fixation
2009 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 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 10 Day
Last modified on
2010 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002827

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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