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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000771
Receipt No. R000000926
Scientific Title Multifactorial effects of insulin sensitizers
Date of disclosure of the study information 2007/07/16
Last modified on 2007/07/16

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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
Email

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
Email sngsk@jichi.ac.jp

Sponsor
Institute Division of Endocrinology and Metabolism, Jichi Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000926

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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