UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011894 |
|---|---|
| Receipt number | R000013900 |
| Scientific Title | Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study) |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2014/10/29 10:52:14 |
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Basic information
Public title
Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)
Acronym
Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)
Scientific Title
Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)
Scientific Title:Acronym
Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)
Region
| Japan |
Condition
Condition
Coronary artery disease, Type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether DPP-4 inhibitor, sitagliptin improves the cardiovascular outcomes and has regressive effects on the atherosclerosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, hospitalization fordecompensated heart failure, coronary revascularization, deep vein thrombosis, pulmonary embolism, or hospitalization for peripheral artery disease)
Key secondary outcomes
All cause death
Hypoglycemic and hyperglycemic coma Event
The change of parameters (GLP-1, BNP, high sensitivity CRP, IL-6 and other biochemical markers, blood pressure, body weight, heart rate, and waist circumference)
Coronary angiography finding (Percent atheroma volume, the change of percent atheroma volume)
The change of parameters in echocardiography
Endothelial function assessed by reactive hyperemia peripheral arterial tonometry
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP4 inhibitor (sitagliptin) treatment group
Interventions/Control_2
Intensification of conventional treatment group
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetes mellitus patients with acute coronary syndrome and stable condition.
2) Coronary artery disease patients with type 2 diabetes mellitus
Patients with coronary artery disease documented by CAG or CT with organic coronary stenosis of >50% in major coronary arteries.
Key exclusion criteria
1) Type 1 diabetes mellitus patients
2) Patients with severe diabetic ketosis, or nonketotic hyperosmolar coma within 6 months preceding enrollment
3) Patients needed treatment by DPP-4 inhibitors
4) Patients receiving GLP-1 receptor analogues injection
5) Patients needed treatment by glinide drugs
6) Patients with active systemic inflammatory disease, severe trauma, before and after the operation, and active hepatic disease
7) Unstable patients with Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, and transient ischemic attack within 1 month preceding enrollment
8) Patients with heart failure (New York Heart Association functional class III and IV, BNP more than 400pg/mL, or left ventricular ejection fraction <35%)
9) Patients planed coronary and peripheral artery revascularization
10) Patients with peripheral ischemic ulcer and gangrene
11) Patients treated by DPP-4 inhibitors at enrollment
12) Patients with pregnant, lactating, or planned or possible pregnant
13) Patients with a history of hypersensitivity to study drug
14) Ineligible patients for any other reasons
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Kumamoto University, Faculty of Life Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Matsubara |
Organization
Kumamoto University, Faculty of Life Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-373-5175
Homepage URL
j-matsu@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2013 | Year | 09 | Month | 27 | 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
| 2011 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013900
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