UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000615 |
|---|---|
| Receipt number | 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 15:04:12 |
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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
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
hotta@chubuh.rofuku.go.jp
Sponsor or person
Institute
The Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT) Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000745
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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