UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.
Acronym	Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.
Scientific Title	Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.
Scientific Title:Acronym	Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison.
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To look at the effect of Vildagliptin on the change of blood sugar level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time spent in range 70-140 mg/dl
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vildagliptin
Interventions/Control_2	Gliclazide
Interventions/Control_3	control (diabetic patients without coronary artery diseases)
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	･Type II diabetes mellitus ･Coronary intervention case ･Age 20-75 y. o. ･Diabetic patients treated with stable low dose of SU (Gliclazide 0~40mg) and/or Metformin (0~750mg) for at least four weeks.
Key exclusion criteria	1) Exclusion criteria will comply with local label 2) Coronary bypass graft operation 3) Severe valvular heart disease 4) Severe arrhythmia (Extrasystole > 10% of total beats, atrial fibrillation, atrial flutter, pacemaker implantation, high grade heart block) 5) Congestive heart failure (NYHA III, IV) 6) Malignant neoplasms 7) Use of gluco-corticosteroids, immuno-suppressant 8) Serum Cr > 2.5 mg/dl 9) Cerebrovascular infarction or hemorrhage 10) Aneurysms in great artery 11) Liver cirrhosis 12) Recent (within 4 weeks) usage of incretin related drugs 13) Blood glucose > 400mg/dl or insulin usage 14) Recent change in diabetic treatment in one month 15) Use of Insulin, GLP-1 analogue, and OHAs excluding SU and metformin
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Taiji Furukawa
Organization	Teikyo university school of medicine
Division name	Department of Clinical Laboratory Medicine
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	tfrkw@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Matsuda
Organization	Teikyo university
Division name	EBM Center
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	mazda@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Novartis Pharma K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 05 Month 19 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	Open public recruiting
Date of protocol fixation	2014 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 19 Day
Last modified on	2015 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020419

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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