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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006537
Receipt No. R000007726
Scientific Title Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Date of disclosure of the study information 2011/10/19
Last modified on 2012/03/05

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Basic information
Public title Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Acronym Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Scientific Title Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Scientific Title:Acronym Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Region
Japan

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

Objectives
Narrative objectives1 Type 2 diabetes complicated with dyslipidemia is well known to be a high risk of arteriosclerotic disease and several drug therapies are performed. No clinical trial has been performed to investigate what treatment of dyslipidemia should be received firstly for patients with type 2 diabetes. The aim of this study is to examine the differential effects on plasma lipid profile and blood sugar among ezetimibe and pravastatin utilizing cross-over design.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change and percent change in TC, LDL-C, HDL-C, TG, Remnant like particle cholesterol (RLP-C), small dense LDL and FFA.
Change and percent change in HbA1c and insulin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of ezetimibe 10mg in the first 3 to 4 months, after one week wash out period, followed by the administration of pravastatin 10mg.
Interventions/Control_2 Administration of pravastatin 10mg in the first 3 to 4 months, after one week wash out period, followed by the administration of ezetimibe 10mg.
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 with type 2 diabetes complicated with dyslipidemia (not taking medication for hyperlipidemia, 120 mg / dl =< LDL in the serum lipid-C < 160 mg / dl, meets TG >= 150 mg / dl)
Key exclusion criteria 1)Patients with hypersensitivity against ezetimibe and pravastatin,
2)Patients with severe renal dysfunction and severe hepatic dysfunction,
3)Pregnant women, women who may be pregnant, and breast-feeding women.
4)Patients with drug-induced and familial dyslipidemia,
5)Patients treated with insulin
6)Patients judged by the investigator/ sub investigator to be ineligible for some other reason.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto Prefectural University of
Division name Department of Endocrinology and Metabolism
Zip code
Address
TEL +81-75-251-5505
Homepage URL
Email

Sponsor
Institute Department of Endocrinology and Metabolism Kyoto Prefectural University of Medicine, Graduate School of Medical Science

Institute
Department

Funding Source
Organization Department of Endocrinology and Metabolism Kyoto Prefectural University of Medicine, Graduate School of Medical Science

Organization
Division
Category of Funding Organization Self funding
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
2011 Year 10 Month 19 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 10 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 13 Day
Last modified on
2012 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007726

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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