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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004367
Receipt No. 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

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Basic information
Public title The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria
Acronym The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria (A-PRIME)
Scientific Title The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria
Scientific Title:Acronym The efficacy of pioglitazone in reduction of urinary albumin excretion in type 2 diabetic patients with microalbuminuria (A-PRIME)
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 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in urinary albumin-to-creatinine ratio (UACR) from baseline to week 52.
Key secondary outcomes Change in HbA1c from baseline to week 52

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Haneda
Organization Asahikawa Medical University
Division name Department of Medicine
Zip code
Address Midorigaoka 2-1, Asahikawa city
TEL 0166-65-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akizuki Morikawa
Organization Asahikawa Red Cross Hospital
Division name Department of Internal Medicine
Zip code
Address Akebono 1-1, Asahikawa city
TEL 0166-22-8111
Homepage URL
Email morikawa@asahikawa-rch.gr.jp

Sponsor
Institute Department of Medicine, Asahikawa Medical University
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company, Japan
Organization
Division
Category of Funding Organization Profit organization
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 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)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.worlddiabetescongress.org/
Number of participants that the trial has enrolled
Results 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)
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
2004 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 11 Day
Last modified on
2010 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005219

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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