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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000681
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Japan Early Diabetes Intervention Study (JEDIS) Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000817

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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