UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Switch to Vildagliptin, oral hypoglycemic agent therapy, from Liraglutide injection (SWITCH-2)
Title of the study (Brief title)	SWITCH-2
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 meal tolerance 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 <200mg/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:3or4 4)pregnancy 5)past history of the allergy to Vildagliptin 6)severe infection, before and after 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	Hiroshi Maegawa
Organization	Shiga University of Medical Science
Division name	Department of Medicine
Address	Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL	077-548-2222
Email

Public contact
Name of contact person	Katsutaro Morino
Organization	Shiga University of Medical Science
Division name	Department of Medicine
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)

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 09 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 31 Day
Anticipated trial start date	2012 Year 08 Month 03 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	While switching to vildagliptin from liraglutide injection, we assess the data and safetiness of outpatient for 6 month.

Management information
Registered date	2012 Year 09 Month 19 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/icdr_e/ctr_view.cgi?recptno=R000010428