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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000615
Receipt No. R000000745
Scientific Title Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)
Date of disclosure of the study information 2007/02/20
Last modified on 2007/02/20

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Basic information
Public title Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)
Acronym Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)
Scientific Title Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)
Scientific Title:Acronym Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)
Region
Japan

Condition
Condition Diabetic peripheral neuropathy
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation on the long-term efficacy and safety of epalrestat, an aldose reductase inhibitor, on diabetic peripheral neuropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change from baseline in median MNCV at 3 years
Key secondary outcomes Other somatic nerve function parameters (minimum F-wave latency [MFWL] of the median motor nerve and vibration perception threshold [VPT]), cardiovascular autonomic nerve function and subjective symptoms

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epalrestat(50mg) was orally administered three times daily before each meal (150 mg/day) with conventional therapies
Interventions/Control_2 Conventional therapy (diet treatment, hypoglycemic agents, insulin, and hypotensive agents)
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

Not applicable
Gender Male and Female
Key inclusion criteria Adults aged =>20 years were diagnosed in each facilities as mild diabetic peripheral neuropathy based on subjective symptoms, no foot ulcer and neurological dysfunctions (at least two parameters; MNCV [indispensable] and VPT or Achilles tendon reflex, etc.). Patients were enrolled for study if they had a median motor nerve conduction velocity (MNCV) =>40 m/s (seemingly reversible) and stable glycemic control (HbA1c <=9%, with +/- 0.5% variation in the previous 3 months).
Key exclusion criteria Subjects were excluded if their primary cause of neurologic disorder was not diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease, etc.), if they had arteriosclerosis obliterans (ankle brachial pressure index of <=0.8), or severe hepatic or renal disorder, if they were participating in other interventional studies, or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Shigeta
Organization Shiga University of Medical Science, Otsu, Japan
Division name Professors Emeritus
Zip code
Address Seta Tsukinowa-cho, Otsu,Shiga 520-2192 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nigishi Hotta
Organization Japan Labour Health and Welfare Organization CHUBU ROSAI HOSPITAL
Division name Director General
Zip code
Address
TEL
Homepage URL
Email hotta@chubuh.rofuku.go.jp

Sponsor
Institute The Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT) Study Group
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2007 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://care.diabetesjournals.org/cgi/content/full/29/7/1538
Number of participants that the trial has enrolled
Results
Over the 3-year period, epalrestat prevented the deterioration of median MNCV, MFWL and VPT seen in the control group.
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
1996 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
1997 Year 04 Month 01 Day
Last follow-up date
2003 Year 09 Month 01 Day
Date of closure to data entry
2004 Year 02 Month 01 Day
Date trial data considered complete
2004 Year 02 Month 01 Day
Date analysis concluded
2004 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 20 Day
Last modified on
2007 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000745

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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