UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007894 |
|---|---|
| Receipt number | R000009280 |
| Scientific Title | Switch to Vildagliptin, oral hypoglycemic agent therapy, from Liraglutide injection |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2017/10/02 21:24:07 |
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Basic information
Public title
Switch to Vildagliptin, oral hypoglycemic agent therapy, from Liraglutide injection
Acronym
SWITCH-1
Scientific Title
Switch to Vildagliptin, oral hypoglycemic agent therapy, from Liraglutide injection
Scientific Title:Acronym
SWITCH-1
Region
| Japan |
Condition
Condition
Type2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the safety of switching from liraglutide injection to Vildagliptin in type 2 diabetic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in clinical features among the successful patients
Key secondary outcomes
1) beta-cell function determined by glucagon loading test
2) incidence of adverse event
3) change in the questionnaire about QOL
4) cost benefit
5) HbA1c and continuation of Vildagliptin at 3 and 6 month after admission
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
1)type2 diabetes treated with Liraglutide or combined therapy with Liraglutide and sulfonylurea
2)5.2%<=HbA1c(JDS)<7.0%
or FBS<110mg/dl and 2h glucose <220mg/dl
3)over 20 years old
4)patients who agree to join the study
Key exclusion criteria
1)severe hepatic dysfunction(ALT or AST more than 2.5times of normal value)
2)undergo dialysis
3)NYHA Classification:3 or 4
4)pregnancy
5)past history of the allergy to Vildagliptin
6)severe infection, before operation, severe trauma
7)patients who need insulin therapy
8)patients who are judged to be ineligible by the investigator for some reason
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Maegawa |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL
077-548-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsutaro Morino |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL
077-548-2223
Homepage URL
Sponsor or person
Institute
Department of Medicine,
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine,
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
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
滋賀医科大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
1)Background
ID,Birth date,Sex,Age,Height,Weight,drug used concomitantly,complications,medical history,Dose of liraglutide
2)somatometry
Weight,Blood pressure,heart rate
3)Blood test
FBS,2H glucose,LDL-C,HDL-C,TG,glycoalbumin,HbA1c
4)SMBG(Self Monitoring of Blood Glucose)
5)U-CPR
6)OGTT,glucagon loading test,meal tolerance test
7)Adverse event
8)questionnaire about QOL
9)cost benefit
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009280
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
