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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017619
Receipt No. R000020419
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.
Date of disclosure of the study information 2015/05/19
Last modified on 2015/05/19

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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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