UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005663 |
|---|---|
| Receipt number | R000006692 |
| Scientific Title | Multicenter observational study of the efficancy of sitagliptin in patients at high risk of cardiovascular disease |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/06/30 18:36:11 |
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Basic information
Public title
Multicenter observational study of the efficancy of sitagliptin in patients at high risk of cardiovascular disease
Acronym
Sitagliptin Registry Kinki Cardiologists'
Study
Scientific Title
Multicenter observational study of the efficancy of sitagliptin in patients at high risk of cardiovascular disease
Scientific Title:Acronym
Sitagliptin Registry Kinki Cardiologists'
Study
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of sitagliptin treatment for patients at high risk of cardiovascular disease
in daily practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The primary end-point is HbA1c measurement every three months for twelve
months after introduction,addition or change from other drugs of sitagliptin in
patinets at high risk of cardiovascular disease who failed to achieve the target blood glucose level despite diet, excise and anti-diabetic drug therapies.
Key secondary outcomes
Other laboratory data, cardiovascular indices and adverse events will be analyzed as well.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
patients with type 2 diabetes mellitus
who failed to achieve the target blood glucose level.
Additionally,patient will be included if
they have more than one folloing item.
hypertension
dyslipidemia
history of cardiovascular diseases
high agesmoking
obesity
hyperuricemia
Key exclusion criteria
history of diabetic ketosis and coma
within 6 month
sepsis,before and after operation,severe injury
pregnant woman,woman with chance of pregnancy
dialysis patient,severe renal dysfunction
hypersensitivity to the medicine
a case determined inappropriate
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Miyazaki |
Organization
Kinki University School of Medicine
Division name
Division of Cardiology,Department of Internal Medicine
Zip code
Address
377-2,Ohno-Higashi,Osaka-Sayama,Osaka
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University School of Medicine
Division name
Division of Cardiology,Department of Internal Medicine
Zip code
Address
1-3-3,nakamichi,higashinariku,Osaka
TEL
06-6976-2071
Homepage URL
http://www.sirkas.jp/
Sponsor or person
Institute
Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka Foundation for the Prevention of Cancer and Cardiovascular Diseases
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
| 2011 | Year | 06 | Month | 01 | 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 | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy and safety of sitagliptin treatment for patients at high risk of cardiovascular disease
in daily practice
Management information
Registered date
| 2011 | Year | 05 | Month | 27 | Day |
Last modified on
| 2011 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006692
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
