UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of efficacy of Teneligliptin and Sitagliptin for glucose fluctuation in Type 2 diabetes
Title of the study (Brief title)	Comparison of efficacy of Teneligliptin and Sitagliptin
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to compare the effectiveness of Teneligliptin and Sitagliptin for glucose fluctuation by using CGM.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum glucose level after supper
Key secondary outcomes	AUC over 140 mg/dl after supper 18-24, AUC over 140 mg/dl after supper 20-24, GLP-1 level at 30 minutes after load, IRI level at 2h after load

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	Teneligliptin 20mg/day for 1 week
Interventions/Control_2	Sitagliptin 50mg/day for 1 week
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	Type 2 diabtes ovet 20 years who provided their informed consent to participate in the study.
Key exclusion criteria	Patients using oral diabetic therapy or insulin therapy, those with mild renal dysfunction (male:s-Cre>1.5, female:s-Cre>1.3), those with severe infectin, those with severe trauma and those with severe liver dysfunction (AST and ALT: 3 times the normal levels) were excluded.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiya Tanaka
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-603-1611
Email	tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person	Akira Kurozumi
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-603-1611
Homepage URL
Email	akira@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department

Funding Source
Organization	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
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 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 10 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 25 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026377