UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007894
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Medicine,
Shiga University of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.