UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002099 |
|---|---|
| Receipt number | 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 15:17:25 |
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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
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
ippei.k@med.shimane-u.ac.jp
Sponsor or person
Institute
Internal Medicine 1, Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002561
| 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 |
