UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000771 |
|---|---|
| Receipt number | R000000926 |
| Scientific Title | Multifactorial effects of insulin sensitizers |
| Date of disclosure of the study information | 2007/07/16 |
| Last modified on | 2007/07/16 15:14:32 |
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Basic information
Public title
Multifactorial effects of insulin sensitizers
Acronym
Multifactorial effects of insulin sensitizers
Scientific Title
Multifactorial effects of insulin sensitizers
Scientific Title:Acronym
Multifactorial effects of insulin sensitizers
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study multifactorial effects of pioglitazone and metformin on insulin secretion and sensitivity, surrogate markers of atherosclerosis, adipocytokines, and appetite-regulating hormones in Type 2 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insulin secretion and sensitivity, surrogate markers of atherosclerosis, adipocytokines, and appetite-regulating hormones
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pioglitazone
Interventions/Control_2
metformin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with HbA1c levels of 6.5-9.0%
Key exclusion criteria
1. treated with insulin
2. renal dysfunction
3. history of heart failure and cerebrovascular disease
4. liver dysfunction
5. pulmonary dysfunction
6. pregnancy or lactation
7. history of side effects by thiazolidinediones or biguanides
8. judged inappropriate for this study by the physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Nagasaka |
Organization
Jichi Medical University
Division name
Division of Endocrinology and Metabolism
Zip code
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL
0285-58-7355
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Nagasaka |
Organization
Jichi Medical University
Division name
Division of Endocrinology and Metabolism
Zip code
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL
0285-58-7355
Homepage URL
sngsk@jichi.ac.jp
Sponsor or person
Institute
Division of Endocrinology and Metabolism, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Endocrinology and Metabolism, Jichi Medical 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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 16 | 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
| 2004 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 16 | Day |
Last modified on
| 2007 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000926
