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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002055
Receipt No. R000002504
Scientific Title Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)
Date of disclosure of the study information 2009/06/09
Last modified on 2010/12/08

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Basic information
Public title Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)
Acronym Effect of pioglitazone on circulating soluble receptor for advanced glycation end-products (PioRAGE)
Scientific Title Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)
Scientific Title:Acronym Effect of pioglitazone on circulating soluble receptor for advanced glycation end-products (PioRAGE)
Region
Japan

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

Objectives
Narrative objectives1 To compare the impact of pioglitazone with glimepiride on serum soluble RAGE(sRAGE) and endogenous secretory RAGE (esRAGE).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes serum soluble form of receptor for advanced glycation end-products(sRAGE), serum endogenous secretory RAGE(esRAGE)
Key secondary outcomes 1)surface RAGE expression on isolated peripheral blood mononuclear cells (PBMCs)
2)serum adiponectin, serum fetuin A, serum TNF-related apoptosis-inducing ligand(TRAIL), serum osteoprotegerin(OPG), serum high sensitivity C-reactive protein(hs-CRP)
3)gene expression of PBMCs(RAGE, ADAM10, ADAM17)
4)serum carboxymethyllysine(CML)

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pioglitazone 15-30 mg/day
Interventions/Control_2 glimepiride 1-4 mg/day
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)subjects who had a baseline glycated hemoglobin(HbA1C) level of 6.0 % or more and below 10.0 %
2)subjects who agreed to participate with written informed concent
Key exclusion criteria 1)subjects currently on pioglitazone therapy
2)subjects under treatment with insulin
3)subjects under treatment with glimepiride 3-6 mg/day or gliclazide 80-160 mg/day or glibenclamide 5-10 mg/day
4)subjects with congestive heart failure
5)subjects with liver cirrhosis
6)subjects with renal dysfunction (serum creatinine level is 2.0 mg/dl or more)
7)subjects with malignant diseases or hard to be followed
8)subjects who were judged to be inappropriate for inclusion
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Nishizawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3806
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3806
Homepage URL
Email stana@med.osaka-cu.ac.jp

Sponsor
Institute PioRAGE research group
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 09 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 No longer recruiting
Date of protocol fixation
2009 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 08 Day
Last modified on
2010 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002504

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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