UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003096 |
|---|---|
| Receipt number | R000003753 |
| Scientific Title | Effect of statins on glucose metabolism in patients with diabetes mellitus |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2010/01/26 11:41:19 |
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Basic information
Public title
Effect of statins on glucose metabolism in patients with diabetes mellitus
Acronym
Effects of statins on glucose metabolism
Scientific Title
Effect of statins on glucose metabolism in patients with diabetes mellitus
Scientific Title:Acronym
Effects of statins on glucose metabolism
Region
| Japan |
Condition
Condition
Hpercholesterolemic patients with impaired glucose tolerance or moderate type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficiency and safety of statins against glucose metabolism in hypercholesterolemic patients with impaired glucose tolerance or moderate type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of influence on glucose metabolism among 3 groups and that of linkage between LDL-C and glucose metabolism
Key secondary outcomes
1) A change of influence on glucose metabolism
2) A change of LDL-C
3)Comparison of efficacy among 3 groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pravastatin 10mg daily for 6 months
Interventions/Control_2
Pitavastatin 2mg daily for 6 months
Interventions/Control_3
Pitavastatin 4mg daily for 6 months
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who
1)are at age of 18 to 80 years at time of consent, male or female
2)are impaired glucose tolerance by 75g oral glucose tolerance test (2-h plasma glucose 140-199 mg/dl)
3)are mild diabetes mellitus by HbA1c<7.0%
4)have Hypercholesterolemia with level of serum LDL-C>/= 140mg/dL(by Friedwald formula of by direct method in the case of patients with level of serum TG 400mg/dl)
5)provide written informed concent for participation in the study
Key exclusion criteria
Patients who
1)have taken statins or are with the use of statins within 4 weeks
2)have severe hypertension (SBP>= 160 mmHg or DB` >= 100 mmHg)
3)have uncontrolled glucose metabolism(change of Hba1c >2%)
4)are judged as being inappropriate for this study by their own doctors
5)are judged as being inappropriate for this study by investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari Takamura |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanazawa University
Division name
Frontier Science Organization
Zip code
Address
TEL
076-234-4207
Homepage URL
tota@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2010 | Year | 01 | Month | 26 | Day |
Last modified on
| 2010 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003753
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
