UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Match-up of two once weekly GLP-1 receptor agonists (exenatide,dulaglutide) about efficacy and satisfaction
Title of the study (Brief title)	Match-up of two once weekly GLP-1 receptor agonists
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare once weekly GLP-1 receptor agonists about efficacy of glucose lowering, weight reduction and satisfaction with treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Satisfaction with treatment (12weeks after treatment)
Key secondary outcomes	HbA1c body weight (12weeks after treatment)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	once weekly exenatide(12 weeks)
Interventions/Control_2	once weekly dulaglutide(12 weeks)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	outpatient age lower limit 20, upper limit 80 HbA1c over 7.0% eGFR over 60 outpatients who agreed to join in our study
Key exclusion criteria	contraindication of GLP-1 receptor agonist taking DPP4-inhibitor using other GLP-1 receptor agonist possibility of precnancy influence of evaluation of intervention drugs
Target sample size	50

Research contact person
Name of lead principal investigator	Masato Odawara
Organization	Tokyo Medical University
Division name	Diabetology, Metabolism, and Endocrinology
Address	6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL	+81-3-3342-6111
Email	odawara@tokyo-med.ac.jp

Public contact
Name of contact person	Junpei Shikuma
Organization	Tokyo Medical University
Division name	Diabetology, Metabolism, and Endocrinology
Address	6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL	+81-3-3342-6111
Homepage URL
Email	inugumitoui@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2018 Year 01 Month 01 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

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026955