UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000107
Receipt No. R000000155
Scientific Title DIAbetes and diffuse coronary Narrowing Analysis Study
Date of disclosure of the study information 2005/09/01
Last modified on 2009/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title DIAbetes and diffuse coronary Narrowing Analysis Study
Acronym DIANA study
Scientific Title DIAbetes and diffuse coronary Narrowing Analysis Study
Scientific Title:Acronym DIANA study
Region
Japan

Condition
Condition Patients with impaired fasting glucose or type-2 diabetes mellitus, who had coronary artery diseases
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether strict glycemic control specifically targeting postprandial hyperglycemia may prevent the development of coronary artery disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lesion length, vessel diameter, percentage diameter stenosis
Key secondary outcomes MACE (all-cause death, non-fatal myocardial infarction, repeat revascularization, the occurrence of anginal chest pain), diabetic complication, the change of % diameter stenosis after PCI, the change of minimum lesional diameter after PCI, the occurrence of restenosis, the development of new stenotic lesion, the change of glycemic status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients treated with voglibose (n=100)
Interventions/Control_2 Patients treated with nateglinide (n=100)
Interventions/Control_3 patients treated without medication, with diet and exercise (n=100)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients who had organic stenosis in coronary angiography
2) patients who were diagnosed as impaired glucose tolerance or diabetes mellitus by a 75g-OGTT
Key exclusion criteria 1) patinets with acute myocardial infarction within 48 hrs
2) patients who previously underwent coronary artery bypass surgery
3) patients who were being treated by anti-diabetic medication
4) patients who had allergic reaction to voglibose or nateglinide
5) patients with real insufficiency (serun creatinine more than 2.0mg/dl)
6) patients who were seriously ill
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichi Miyazaki
Organization National Cardiovascular Center
Division name Division of Cardiology
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cardiovascular Center
Division name The Division of Atheroscierosis, Metabolism and Clinical Nutrition
Zip code
Address
TEL 06-6833-5012
Homepage URL
Email

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Cardiovascular Research 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
2005 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2004 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 07 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 01 Day
Last modified on
2009 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.