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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008344
Receipt No. R000009773
Official scientific title of the study 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 2016/10/01

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Basic information
Official scientific title of the study The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in diabetic patients with coronary artery disease
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Toshiro Shinke
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
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 Masaru Kuroda
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL +81-78-382-5846
Homepage URL
Email kuroro19800115@hotmail.com

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 06 Month 25 Day
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2012 Year 07 Month 04 Day
Last modified on
2016 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009773


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