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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002099
Receipt No. R000002561
Scientific Title Effects of metformin and pioglitazone on serum pentosidine levels in type 2 diabetes mellitus
Date of disclosure of the study information 2009/06/21
Last modified on 2009/06/21

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Basic information
Public title Effects of metformin and pioglitazone on serum pentosidine levels in type 2 diabetes mellitus
Acronym Effects of metformin and pioglitazone on pentosidine
Scientific Title Effects of metformin and pioglitazone on serum pentosidine levels in type 2 diabetes mellitus
Scientific Title:Acronym Effects of metformin and pioglitazone on pentosidine
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to investigate the effects of metformin or pioglitazone on serum pentosidine levels
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the effects of metformin or pioglitazone on serum pentosidine levels
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are 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 treatment with metformin
Interventions/Control_2 treatment with pioglitazone
Interventions/Control_3 treatment of sulfonylurea or insulin
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 diabetes mellitus
Key exclusion criteria Nobody had hepatic or renal dysfunction or nutritional derangements. Patients who had taken metformin or pioglitazone in the past were excluded from this study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ippei Kanazawa
Organization Shimane University Faculty of Medicine
Division name Internal Medicine 1
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ippei Kanazawa
Organization Shimane University Faculty of Medicine
Division name Internal Medicine 1
Zip code
Address
TEL
Homepage URL
Email ippei.k@med.shimane-u.ac.jp

Sponsor
Institute Internal Medicine 1, Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Self funding
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
2009 Year 06 Month 21 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
In the metformin group and pioglitazone groups, serum pentosidine levels were significantly decreased at 6 months.
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
2007 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 21 Day
Last modified on
2009 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002561

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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