UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010247 |
|---|---|
| Receipt number | R000011994 |
| Scientific Title | Effect of Vildagliptin and Glimepiride in acute myocardial infarction patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2013/03/14 18:04:23 |
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Basic information
Public title
Effect of Vildagliptin and Glimepiride in acute myocardial infarction patients with type 2 diabetes
Acronym
Effect of Vildagliptin and Glimepiride in acute myocardial infarction patients with type 2 diabetes
Scientific Title
Effect of Vildagliptin and Glimepiride in acute myocardial infarction patients with type 2 diabetes
Scientific Title:Acronym
Effect of Vildagliptin and Glimepiride in acute myocardial infarction patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Acute myocardial infarction (AMI) patients with type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Vildagliptin and Glimepiride in AMI patients with type 2 diabetes of the effect on acute phase glucose fluctuation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of acute phase flucose fluctuation and myocardial salvage index in AMI patients with type 2 diabetes
Key secondary outcomes
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
7 days treatments of Vildagliptin on acute phase of AMI
Interventions/Control_2
7 days treatments of Glimepiride on acute phase of AMI
Interventions/Control_3
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.AMI patients with type 2 diabetes
2.Informed consent obtained.
Key exclusion criteria
1.AMI for more than 24 hour from onset
2.Contraindicated of Vildagliptin and Glimepiride
3.Renal dysfunction, serum creatinine ≥1.5 mg/dl
4.Informed consent can not be obtained.
5.Patients judged to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Teraguchi |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
811-1, Kimiidera, Wakayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
811-1, Kimiidera, Wakayama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 14 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2013 | Year | 03 | Month | 14 | Day |
Last modified on
| 2013 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011994
