UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012562 |
|---|---|
| Receipt number | R000014091 |
| Scientific Title | Investigation of pleiotropic effect of DPP-4 inhibitor, sitagliptin for type 2 diabetic patients with old myocardial infarction |
| Date of disclosure of the study information | 2013/12/12 |
| Last modified on | 2018/01/18 19:51:53 |
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Basic information
Public title
Investigation of pleiotropic effect of DPP-4 inhibitor, sitagliptin for type 2 diabetic patients with old myocardial infarction
Acronym
Mie University study of sitagliptin pleiotropic effect for diabetic patients with old myocardial infarction (MUSIC FAIR)
Scientific Title
Investigation of pleiotropic effect of DPP-4 inhibitor, sitagliptin for type 2 diabetic patients with old myocardial infarction
Scientific Title:Acronym
Mie University study of sitagliptin pleiotropic effect for diabetic patients with old myocardial infarction (MUSIC FAIR)
Region
| Japan |
Condition
Condition
type 2 diabetic patients with old myocardial infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare cardiovascular effects of DPP-4 inhibitor, sitagliptin wiht alpha glucosidase inhibitor, voglibose for type 2 diabetic patients with old myocardial infarction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in myocardial perfusion reserve by cardiac MRI after 6 months of treatment
Key secondary outcomes
1. Changes in myocardial fibrosis by cardiac MRI after 6 months of treatment
2. Changes in left ventricular end-diastolic volume, end-systolic volume, and ventricular mass by cardiac MRI after 6 months of treatment
3. Changes in RH-PAT index by reactive hyperemia peripheral arterial tonometry after 6 months of treatment
4. Changes in home blood pressure after 6 months of treatment
5. adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group receiving sitagliptin
Interventions/Control_2
Group receiving voglibose
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes who had received diet and exercise therapy or diet, exercise and pharmacologic therapy with oral antidiabetic agents for more than 2 months and whose blood glucose have not been sufficiently controlled (6.5%<=HbA1c [NGSP]<9.0%)
2. Patients with myocardial infarction former more than 6 months and stable condition at registration
3. Patients aged >=20 years
4. Patients who have given written informed consent to participate in the study
Key exclusion criteria
1. Patients with type 1 diabetes
2. Patients who had a history of severe ketosis, diabetic coma or precoma within 6 mnths
3. Patients who had a history of acute myocardial infarction and unstable angina
4. Patients who had a history of coronary bypass surgery, prosthetic replacement and pacemaker implantation
5. Patients with severe heart failure (NYHA IV)
6. Patients with transient and persistent atrial fibrillation
7. Patients before or after operation, and those with severe infections or serious injury
8. Pregnant, possible pregnant, or lactating women
9. Patinets with severe kidney dysfunction (eGFR: <30mL/min or patients under dialysis)
10. Patients with severe liver dysfunction
11. Patients that cardiac MRI is contraindicated
12. Patients receiving insulin or GLP-1 receptor analogues injection
13. Patients receiving glinide and alpha glucosidase inhibitor
14. Patients with a history of hypersensitivity to the study drug
15. Patients receiving DPP-4 inhibitor
16. Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5015
dohik@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsushiro Takeuchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5015
Homepage URL
tetsu-take@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, MUSIC FAIR Project Office
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Waksman Foundation of Japan INC.
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
三重大学病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014091
