UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008344
Receipt number R000009773
Scientific Title The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in diabetic patients with coronary artery disease
Date of disclosure of the study information 2012/07/04
Last modified on 2022/04/25 10:50:58

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Basic information

Public title

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

Acronym

the IMpact of sitAgliptin on daily Glucose profIle and coroNary plaquE character in diabetic patients with coronary artery disease:IMAGINE-KOBE study

Scientific Title

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

Scientific Title:Acronym

the IMpact of sitAgliptin on daily Glucose profIle and coroNary plaquE character in diabetic patients with coronary artery disease:IMAGINE-KOBE study

Region

Japan


Condition

Condition

patients with coronary artery disease and type 2 diabetes

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of sitagliptine versus metformine on daily glucose profile analyzed by 24-hour continuous glucose monitoring system and coronary plaque character using coronary imaging devices in diabetic 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 sitagliptin in comparison with metformine

Key secondary outcomes



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

Sitagliptin group:start with Sitagliptin 50 mg/day and up to 100 mg/day

Interventions/Control_2

Metformin group:Metformin 500 mg/day and up to 1000 mg/day

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)In patients undergoing PCI, "untreated diabetes" and "HbA1c(NGSP) between 6.5 and 8.4, or FBS > 126mg/dl or casual blood glcose > 200mg/dl"
2)LDL-chol < 100mg/dl in patients without statin. LDL-chol < 120mg/dl in patients with statin.
3)patients between 20 and 75 years old
4)Written consent for participation in the study

Key exclusion criteria

Patients meeting one of the following conditions will be excluded:
1) poor control:HbA1c(NGSP)>8.5, or under treatment of diabetes, or type 1 diabetes
2)severe liver dysfunction
3)severe renal dysfunction (Cre 1.3 mg/dL)
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

44


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

078-382-5111

Email

shinke@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Yamamoto

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

650-0017

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN

TEL

+81-78-382-5846

Homepage URL


Email

y0493589m@hotmail.co.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

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

Tel

078-382-5846

Email

y0493589m@hotmail.co.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 07 Month 04 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

Completed

Date of protocol fixation

2012 Year 06 Month 25 Day

Date of IRB

2012 Year 06 Month 25 Day

Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 30 Day

Date of closure to data entry

2019 Year 03 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 07 Month 04 Day

Last modified on

2022 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name