UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of pleiotropic effect of DPP-4 inhibitor, sitagliptin for type 2 diabetic patients with old myocardial infarction
Title of the study (Brief title)	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	Kaoru Dohi
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-231-5015
Email	dohik@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Tetsushiro Takeuchi
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-231-5015
Homepage URL
Email	tetsu-take@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, MUSIC FAIR Project Office
Institute
Department

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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014091