UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in type 2 diabetic patients with coronary artery disease
Title of the study (Brief title)	VIBRATE-J study
Region	Japan

Condition
Condition	Type 2 diabetic patients with coronary artery disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in diabetic patients with CAD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of blood glucose, insulin, and lipids
Key secondary outcomes	Changes of vascular endothelial function

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	Vildagliptin
Interventions/Control_2	Metformin
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with HbA1 >= 6.9% (NGSP) even after dietary and exercise therapies 2) Patients with CAD 3) Patients who give informed consent 4) Patients aged 20 years or older
Key exclusion criteria	1) Patients who has a history of adverse events with vildagliptin or biganide 2) Patients treated with antidiabetes agents 3) Ongoing treatment with insulin 4) Patients with diabetic ketoacidosis or diabetic coma or type 1 diabetes 5) Patients with severe liver dysfunction 6) Patients with moderate or severe renal disorders (creatinine level >= 1.5 mg/dL [men] or >= 1.3 mg/dL [women]) 7) Pregnant or nursing women 8) Patients with severe illness 9) Patients who judged as ineligible by clinical investigators
Target sample size	20

Research contact person
Name of lead principal investigator	Kazunori Shimada
Organization	Juntendo University School of Medicine
Division name	Department of Cardiology
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Email	shimakaz@juntendo.ac.jp

Public contact
Name of contact person	Kazunori Shimada
Organization	Juntendo University School of Medicine
Division name	Department of Cardiology
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	shimakaz@juntendo.ac.jp

Sponsor
Institute	Department of Cardiology, Juntendo University 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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 19 Day
Anticipated trial start date	2013 Year 04 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	2013 Year 04 Month 30 Day
Last modified on	2016 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012423