Unique ID issued by UMIN | UMIN000004367 |
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Receipt number | R000005219 |
Scientific Title | The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria |
Date of disclosure of the study information | 2010/10/12 |
Last modified on | 2010/10/11 10:31:59 |
The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria
The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria (A-PRIME)
The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria
The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria (A-PRIME)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare the efficacy of pioglitazone added to RAS-inhibitor in reduction of urinary albumin excretion with that of metformin added to RAS-inhibitor, in type 2 diabetic patients with microalbuminuria.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to week 52.
Change in HbA1c from baseline to week 52
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is considered as a block.
NO
Numbered container method
2
Treatment
Medicine |
After treatment of hypertension at least 12 weeks with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACE-Is) in usual dose, patients receive pioglitazone 15mg/day. Pioglitazone dose is titrated up to 30 mg after 4 weeks and maintained to 52 weeks of treatment.
After treatment of hypertension at least 12 weeks with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACE-Is) in usual dose, patients receive metformin 500 or 750mg/day. Metformin dose is titrated up to 750mg/day to achieve HbA1c less than 6.9%, and maintained to 52 weeks of treatment.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1.Type 2 diabetic patient
2.Patient who is treated with diet alone, insulin or oral hypoglycemic agents except metformin and/or pioglitazone (only clinically used thiazolidinedione in Japan). If metformin and/or pioglitazone had already been administered, they were withdrawn from patient at 4 weeks before screening.
3.HbA1c between 6.9% and 9.4% with stable glycemic control
4.Patient who is receiving anti-hypertensive treatment with RAS-Is over 12 weeks.
5.Patient with microalbuminuria (defined by twice measured urinary albumin-to-creatinine ratio of 30 mg/gCr or greater and less than 300 mg/gCr in first morning urine samples in the screening period.
1.serum creatinine >1.5 mg/dl at baseline
2.a history of side effects with pioglitazone or metformin.
3.present or past history of congestive heart failure, myocardial infarction, pulmonary embolism.
4.alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > twofold the upper limit of normal.
5.pregnancy
100
1st name | |
Middle name | |
Last name | Masakazu Haneda |
Asahikawa Medical University
Department of Medicine
Midorigaoka 2-1, Asahikawa city
0166-65-2111
1st name | |
Middle name | |
Last name | Akizuki Morikawa |
Asahikawa Red Cross Hospital
Department of Internal Medicine
Akebono 1-1, Asahikawa city
0166-22-8111
morikawa@asahikawa-rch.gr.jp
Department of Medicine, Asahikawa Medical University
Takeda Pharmaceutical Company, Japan
Profit organization
NO
旭川赤十字病院(旭川市)、吉田病院(旭川市)、自由が丘横山内科クリニック(帯広市)、市立旭川病院(旭川市)、おおしま内科(旭川市)、旭川厚生病院(旭川市)、札幌厚生病院(札幌市)
2010 | Year | 10 | Month | 12 | Day |
Partially published
http://www.worlddiabetescongress.org/
After 52weeks of treatment, the mean urinary albumin-to-creatinine ratio decreased significantly in the pioglitazone add-on to RAS inhibitor group compared to that in the metformin group (p < 0.05 between groups), with similar glycemic and blood pressure changes.
(parts of this study were presented at the 20th World Diabetes Congress, Montreal, 18-22 October 2009.abstract number D-0819)
Completed
2004 | Year | 12 | Month | 24 | Day |
2005 | Year | 01 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 04 | Month | 01 | Day |
2008 | Year | 06 | Month | 01 | Day |
2009 | Year | 02 | Month | 01 | Day |
2010 | Year | 10 | Month | 11 | Day |
2010 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005219
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