UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000107
Receipt number 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 12:13:37

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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 or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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