UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000681 |
|---|---|
| Receipt number | R000000817 |
| Scientific Title | A Randomized Comparative Clinical Study on Suppression of Progression from Early Diabetes, Diet/exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention |
| Date of disclosure of the study information | 2007/04/18 |
| Last modified on | 2007/04/19 11:21:39 |
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Basic information
Public title
A Randomized Comparative Clinical Study
on Suppression of Progression from Early Diabetes, Diet/exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
Acronym
Japan Early Diabetes Intervention Study (JEDIS)
Scientific Title
A Randomized Comparative Clinical Study
on Suppression of Progression from Early Diabetes, Diet/exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
Scientific Title:Acronym
Japan Early Diabetes Intervention Study (JEDIS)
Region
| Japan |
Condition
Condition
Newly-diagnosed early diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening or progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Progression/worsening to definite diabetes mellitus:
Subjects are judged to have progressed to definite diabetes when FPG >= 140mg/dl and HbA1c >= 7.0% are confirmed more than one occasion by central Progression and Safety Assessment committee.
Key secondary outcomes
- Progression to warning glycemic level: Progression to a glycemic level warning means that more aggressive intervention should be done, for subjects with FPG >= 126 and HbA1c >= 6.5%
- Appearance of diabetic microangiopathy (retinopathy or nephropathy)
- Appearance of macroangiopathy
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
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Standard lifestyle guidance
Interventions/Control_2
Standard lifestyle guidance and pharmacological intervention (monotherapy with acarbose)
Interventions/Control_3
Standard lifestyle guidance and pharmacological intervention (monotherapy with metformin)
Interventions/Control_4
Standard lifestyle guidance and pharmacological intervention (monotherapy with gliclazide)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Results of 75-g oral glucose tolerance test (75 g OGTT) conducted after candidate selection or, if available, results of 75 g OGTT conducted within the past 3 months, will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL (isolated post-challenge hyperglycemia [IPH]) and HbA1c <= 6.9%
- If these are confirmed, 75-g OGTT will be re-tested within 3 months and if the results again show an IPH pattern as well as HbA1c of <= 6.9%, the person will be confirmed to have a diagnosis of newly diagnosed early diabetes, and then could be enrolled in the study.
Key exclusion criteria
a. Type 1 diabetes mellitus
b. Undergoing treatment with steroids
c. Secondary diabetes mellitus
d. Diabetes mellitus due to suspected mitochondrial gene abnormalities or other gene abnormalities
e. Very obese (BMI >= 35 kg/m2) or underweight (BMI < 18.5 kg/m2)
f. Undergone a gastrectomy or abdominal surgery
g. Severe hyperuricemia (gout) associated with organ dysfunction caused by hyperuricemia
h. Severe vascular diseases with organ dysfunction
i. Cancer or other malignant neoplasms
j. Liver cirrhosis or chronic hepatic, chronic renal failure
k. Gastrointestinal disorders such as diarrhea and vomiting
l. Always performing rigorous muscular exercise
m. Severe infection or serious trauma or, who are scheduled to undergo or who have just undergone surgery
n. Women who are pregnant or with a possibility of pregnancy
o. Alcohol dependence or drug dependence
p. Drug allergy
q. Anemic (males: Hb < 13 g/dL; females: Hb < 11 /dL)
r. Abnormal hemoglobinuria.
s. Severe mental disease undergoing treatment,
Other individuals whom the investigator deems unsuitable for inclusion in this study (e.g., individuals who are very likely to be transferred to another locality during the course of the study)
Target sample size
2560
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kuzuya |
Organization
Jichi Medical University
Division name
Honorary professor
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japan Early Diabetes Intervention Study Bureau
Division name
None
Zip code
Address
TEL
03-3814-8010
Homepage URL
Sponsor or person
Institute
Japan Early Diabetes Intervention Study (JEDIS) Group
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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 | 04 | Month | 18 | Day |
Related information
URL releasing protocol
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
Date of protocol fixation
| 2007 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 17 | Day |
Last modified on
| 2007 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000817
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