UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017619 |
|---|---|
| Receipt number | 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 17:55:44 |
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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
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
mazda@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020419
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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