Unique ID issued by UMIN | UMIN000002055 |
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Receipt number | 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 14:13:31 |
Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)
Effect of pioglitazone on circulating soluble receptor for advanced glycation end-products (PioRAGE)
Multicenter clinical trial of pioitazone in type 2 diabetes: impact on expression of soluble receptor for advanced glycation end-products (PioRAGE)
Effect of pioglitazone on circulating soluble receptor for advanced glycation end-products (PioRAGE)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare the impact of pioglitazone with glimepiride on serum soluble RAGE(sRAGE) and endogenous secretory RAGE (esRAGE).
Efficacy
Exploratory
Pragmatic
Phase IV
serum soluble form of receptor for advanced glycation end-products(sRAGE), serum endogenous secretory RAGE(esRAGE)
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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
pioglitazone 15-30 mg/day
glimepiride 1-4 mg/day
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Yoshiki Nishizawa |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
06-6645-3806
1st name | |
Middle name | |
Last name | Shinji Tanaka |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
06-6645-3806
stana@med.osaka-cu.ac.jp
PioRAGE research group
Osaka City University Graduate School of Medicine
Self funding
Japan
NO
2009 | Year | 06 | Month | 09 | Day |
Unpublished
No longer recruiting
2009 | Year | 04 | Month | 15 | Day |
2009 | Year | 06 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2009 | Year | 06 | Month | 08 | Day |
2010 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002504
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