UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparative study of the impact of differences in the timing of oral DPP4 inhibitor in type 2 diabetes is on the glycemic control.
Title of the study (Brief title)	Oral timing of DPP4 inhibitor
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The difference in the timing of oral DPP4 inhibitor is a comparative study on the effects on glycemic control in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes

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	Differences of oral timing
Interventions/Control_2	Differences of oral timing
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	HbA1c < 7.5%
Key exclusion criteria	What you are using three or more agents of oral hypoglycemic agents other than DPP4 inhibitor.
Target sample size	6

Research contact person
Name of lead principal investigator	Michiaki Fukui
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5506
Email	michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person	Muhei Tanaka
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL	075-251-5506
Homepage URL
Email	muhei-t@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Organization
Division
Category of Funding Organization	Other
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 03 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 02 Day
Last follow-up date
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	2015 Year 09 Month 12 Day
Last modified on	2017 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021964