UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009156 |
|---|---|
| Receipt number | 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 14:46:28 |
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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
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
t126022b@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City Unuversity School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010736
