UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009156
Receipt No. R000010736
Scientific Title Study for effects of rosuvastatin on glucose and lipid metabolism in patients with type 2 diabeteic patients
Date of disclosure of the study information 2012/10/20
Last modified on 2015/06/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study for effects of rosuvastatin on glucose and lipid metabolism in patients with type 2 diabeteic patients
Acronym Effects of rosuvastatin on glucose and lipid metabolism
Scientific Title Study for effects of rosuvastatin on glucose and lipid metabolism in patients with type 2 diabeteic patients
Scientific Title:Acronym Effects of rosuvastatin on glucose and lipid metabolism
Region
Japan

Condition
Condition Type 2 diabeteic patients with dyslipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluate of effects of rosuvastatin on glucose and lipid metabolism in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of HbA1c, nonHDL-C, T-C, LDL-C, HDL-C from the baseline to 6 months later.
Key secondary outcomes Change of C-peptide, sd-LDL, MDA-LDL, Apo-B, Apo-AI, Cystatin C,high-molecular-weight adoponectin, TNF-alpha from the baseline to 6 months later.

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 Rosuvastatin 5mg/day
(Patients under other statins are switched to rosuvastatin at the dose of 5 mg/day.)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with type 2 diabetes
2)Patients with other statins for more 2 months
3)LDL-C >= 100 mg/dl
Key exclusion criteria 1)HbA1c>=9.4 %(NGSP)
2)Patients with type 1 diabetes,Severe ketosis,Diabetic coma
3)Patients with hyperkalemia
4)Patients with severe liver failure or renal failure
5)Patient with severe infection, perioperative,severe trauma
6)Pregnant and possibly pregnant women
7)Patients having liver failure,and getting a rash for statins
8)Other patients determined to be inappropriate by physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City Unuversity School of Medicine
Division name Department of Endcrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama City ,Kanagawa,Japan
TEL 045-787-2800
Email terauchi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Kameda
Organization Yokohama City Unuversity School of Medicine
Division name Department of Endcrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama City ,Kanagawa,Japan
TEL 045-787-2800
Homepage URL
Email t126022b@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City Unuversity School of Medicine
Institute
Department

Funding Source
Organization none
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 横浜市立大学附属病院(神奈川県)(Yokohama City University Hospital),藤沢湘南台病院(神奈川県)(Fujisawa Shounandai Hospital)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 20 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 Completed
Date of protocol fixation
2012 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 05 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
2012 Year 10 Month 20 Day
Last modified on
2015 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010736

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.