UMIN-CTR Clinical Trial

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
Institute	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009773