UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008992 |
|---|---|
| Receipt number | R000010549 |
| Scientific Title | Randomized control study on effect and safety in patients with type2 diabetes between patients who keep on using current amount of SU and patients who decrease current amount of SU in half : JDDM multi-center study |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2014/10/02 17:31:45 |
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Basic information
Public title
Randomized control study on effect and safety in patients with type2 diabetes between patients who keep on using current amount of SU and patients who decrease current amount of SU in half : JDDM multi-center study
Acronym
Randomized control study on effect and safety in patients with type2 diabetes between patients who keep on using current amount of SU and patients who decrease current amount of SU in half : JDDM multi-center study
Scientific Title
Randomized control study on effect and safety in patients with type2 diabetes between patients who keep on using current amount of SU and patients who decrease current amount of SU in half : JDDM multi-center study
Scientific Title:Acronym
Randomized control study on effect and safety in patients with type2 diabetes between patients who keep on using current amount of SU and patients who decrease current amount of SU in half : JDDM multi-center study
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating by conducting a prospective study, how many patients can decrease their amount of SU in half in patients who could have got good glycemic control using OHAs including SU.
Furthermore investigating influence on body weight by conducting this study is important.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in glycemic control among two groups
Key secondary outcomes
Changes in body weight among two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1 : Decreases the amount of SU in half and observes 3 months period.
Interventions/Control_2
Group 2 : Keeps on using the amount of SU and observes 3 months period.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes who are their age between 18 and 79.
2. Patients who continues to use SU at least three months.
3. Patients who continues their HbA1c below 7.4% at least three months.
4. Patients who can get written informed consent before enrolling the study.
Key exclusion criteria
1. Patients having asymptomatic hypoglycemia or serious hypoglycemia.
2. Patients having their GOT higher than 80 IU/L or having their GPT higher than 80 IU/L.
3. Patients having their CRE higher than 1.7mg/dL.
4. Patients having vicious tumor or having a career of vicious tumor and a possibility to act up it.
5. Patients enrolling other
clinical trials.
6. Patients receiving insulin therapy within 12 weeks.
7. Patients receiving steroid therapy entire body or planing to receive it in near future.
8. Patients who identified as improper by Drs
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kurihara |
Organization
Kurihara internal medicine
Division name
Director of the clinic
Zip code
Address
Atsubetsu-chuo 3-5, Sapporo city, Hokkaido, Japan
TEL
011-892-3522
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Kurihara |
Organization
Kurihara internal medicine
Division name
Director of the clinic
Zip code
Address
Atsubetsu-chuo 3-5, Sapporo city, Hokkaido, Japan
TEL
011-892-3522
Homepage URL
ykuri@yg7.so-net.ne.jp
Sponsor or person
Institute
Japan Diabetes Foundation
Institute
Department
Personal name
Funding Source
Organization
JDDM
Organization
Division
Category of Funding Organization
Other
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
栗原内科（北海道）、横山内科クリニック（北海道）、岩崎内科医院（山口県）、岡田内科クリニック（福岡県）、社会保険高岡病院（富山県）、杉本クリニック（福岡県）、高村内科クリニック（東京都）、大石内科クリニック（京都府）、みやざわ循環器内科（北海道）、ともながクリニック（東京都）、川井クリニック（茨城県）、わかまつ内科クリニック（秋田県）、筑紫南ヶ丘病院（福岡県）、奥口内科クリニック（宮城県）、山形県立中央病院（山形県）、ほか
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://jddm.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010549
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| Registered date | File name |
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