UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008620
Receipt number R000010058
Scientific Title The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease
Date of disclosure of the study information 2012/08/06
Last modified on 2022/03/15 18:50:33

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Basic information

Public title

The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease

Acronym

the impact of Vildagliptin On daily Glucose profile and coronary plaqUE character in impaired glucose tolerance patients with coronary artery disease:VOGUE-KOBE

Scientific Title

The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease

Scientific Title:Acronym

the impact of Vildagliptin On daily Glucose profile and coronary plaqUE character in impaired glucose tolerance patients with coronary artery disease:VOGUE-KOBE

Region

Japan


Condition

Condition

patients with coronary artery disease and impaired glucose tolerance (IGT)

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of vildagliptin versus conventional treatment without DDP-4 inhibitor on daily glucose profile analyzed by 24-hour continuous glucose monitoring system and coronary plaque character using coronary imaging devices in IGT patients with coronary artery disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in coronary plaque character analyzed by coronary angiography, intravascular ultrasound, and optical coherence tomography, and daily glucose profile analyzed by 24-hour continuous glucose monitoring system before and after 6 months treatment with vildagliptin in comparison with conventional treatment without DPP-4 inhibitor

Key secondary outcomes

1)Changes in the IMT value measured by carotid arterial echography
2)Changes in HbA1c (NGSP) and 75g OGTT (glucose and insulin levels after glucose load)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vildagliptin group:start with Vildagliptin 50 mg/day

Interventions/Control_2

Diet and exercise without DPP-4 inhibitotr

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)In patients undergoing PCI, "untreated IGT" and "2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL in a 75g oral glucose tolerance test"
2)LDL-chol < 100mg/dl in patients without statin. LDL-chol < 120mg/dl in patients with statin.
3)patients between 20 and 80 years old
4)Written consent for participation in the study

Key exclusion criteria

Patients meeting one of the following conditions will be excluded:
1)under treatment of diabetes, or type 1 diabetes
2)severe liver dysfunction
3)severe renal dysfunction
4)severe heart failure) (NYHA/New York Heart Association stage III or severer)
5)Malignancies or other diseases with poor prognosis
6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) past medical history of hypersensitivity to investigational drugs
8) judged as ineligible by clinical investigators

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Toshiro
Middle name
Last name Shinke

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5846

Email

shinke@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Toshiro
Middle name
Last name Shinke

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5846

Homepage URL


Email

shinke@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Division of diabetes and metabolism, Kobe University Graduate School of Medicine
Hyogo Brain and Heart Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University Graduate School of Medicine

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

Tel

+81-78-382-5846

Email

shinke@med.showa-u.ac.jp


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

2012 Year 08 Month 06 Day


Related information

URL releasing protocol

https://bmccardiovascdisord.biomedcentral.com/track/pdf/10.1186/s12872-021-01902-0.pdf

Publication of results

Published


Result

URL related to results and publications

https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-01902-0

Number of participants that the trial has enrolled

24

Results

Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group.
These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset.

Results date posted

2022 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients included in this study satisfied the following criteria: (1) scheduled to undergo percutaneous coronary intervention (PCI) for stable CAD with an untreated IGT(2) under lipid-lowering management; low-density lipoprotein cholesterol<120 mg/dl with statin administration, and<100 mg/dl without statin administration, (3) between 20 and 80 years old, and 4) having provided written informed consent for participation in the study.

Participant flow

a multicenter, open-label, randomized
controlled trial at two institutes in Japan

Adverse events

nothing

Outcome measures

In this trial protocol, the primary endpoint was changes in coronary plaque characteristics, such as the minimum FCT and lipid arc detected by OCT between baseline and
6 months after intervention, and those in the MAGE. The following OCT parameters were determined for analysis: the minimum lumen area, lipid length, lipid mean arc, and minimum FCT for quantitative variables.
As outcomes of glycemic metabolic variables, the MAGE, time in hyperglycemia/ hypoglycemia, and mean, maximum, and minimum blood glucose levels were measured. As clinical outcome, cardiac death, myocardial infarction (MI), cerebral infarction, target
lesion revascularization (TLR), and target vessel revascularization (TVR) were set.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 07 Month 04 Day

Date of IRB

2012 Year 07 Month 04 Day

Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

2019 Year 03 Month 30 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 08 Month 05 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name