UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011117 |
|---|---|
| Receipt number | R000013027 |
| Scientific Title | The effect of sitagliptin or alogliptin on blood glucose levels and vascular endothelial function in type2 diabetes |
| Date of disclosure of the study information | 2013/07/04 |
| Last modified on | 2015/02/04 13:58:11 |
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Basic information
Public title
The effect of sitagliptin or alogliptin on blood glucose levels and vascular endothelial function in type2 diabetes
Acronym
SILVER
Scientific Title
The effect of sitagliptin or alogliptin on blood glucose levels and vascular endothelial function in type2 diabetes
Scientific Title:Acronym
SILVER
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 compare blood glucose levels and vascular endothelial function under treatment by Aloglirtin or sitagliptin using CGM in type 2 diabetes patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of HbA1c levels and rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
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
Sitagliptin Group (Sample size 10 ) 3Months
Interventions/Control_2
Alogliptin Group (Sample size 10 ) 3Months
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
type 2 diabetes mellitus
hemoglobin A1c 6.5% and above (NGSP)
Key exclusion criteria
1)Serum creatine levels are 1.5mg/dL
(male)and 1.3mg/dL(female) or more.
2)Patients with taking glinides or GLP-1
3) Patients sufferd from severe ketosis,
diabetic coma or semi-coma within 6-
month before participating the study 4)
Patients sufferd from severe infection
or trauma, and perioperative
5)Possible or definitive pregnant women
or nursing mother
6) Patients with history of
hypersensitivity to any ingredients of
sitagliptin and alogliptin tablets
7)Patients with taking DPP-4
Inhibitor
Other patients deemed not appropliate for participating to the study by investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Shimomura |
Organization
Fukuoka Tokushukai Hospital
Division name
Department of Cardiology
Zip code
Address
Sugukita 4-5 Kasuga city,Fukuoka Japan
TEL
092-573-6622
t-chiken@csf.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yamada |
Organization
Fukuoka Tokushukai Hospital
Division name
Department of Cardiology
Zip code
Address
Sugukita 4-5 Kasuga city,Fukuoka Japan
TEL
092-573-6622
Homepage URL
y_yuko@csf.ne.jp
Sponsor or person
Institute
Fukuoka Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Tokushukai Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 04 | 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 | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2015 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013027
