UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Title of the study (Brief title)	The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Region	Japan

Condition
Condition	non-alcoholic fatty liver disease/type 2 diabetes mellitus
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of teneligliptin in non-alcoholic fatty liver disease with type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	improvement in liver stiffness
Key secondary outcomes	improvement in physical findings and laboratory data

Base
Study type	Interventional

Study design
Basic design	Parallel
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	administration of teneligliptin with diet and exercise therapy
Interventions/Control_2	diet and exercise therapy only (and administration of glimepiride as needed)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) The subjects with fatty liver and more than or equal to 30IU/L of ALT 2) The subjects with more than or equal to 6.0% and less than 8.0% of HbA1c
Key exclusion criteria	1) intake more than 20g/day of ethanol 2) HBsAg and/or HCV Ab positive 3) history of hepatic disease, such as autoimmune liver disease, hemochromatosis and Wilson's disease 4) history of diabetes ketosis and/or diabetic coma 5) during pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	Tomoaki Nakajima
Organization	Sapporo Kosei General Hospital
Division name	Department of hepatology
Address	Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan
TEL	011-261-5331
Email	t.nakajima@ja-hokkaidoukouseiren.or.jp

Public contact
Name of contact person	Tomoaki Nakajima
Organization	Sapporo Kosei General Hospital
Division name	Department of hepatology
Address	Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan
TEL	011-261-5331
Homepage URL
Email	t.nakajima@ja-hokkaidoukouseiren.or.jp

Sponsor
Institute	Sapporo Kosei General Hospital, Department of Hepatology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto Prefectural University of Medicine, Department of endocrinology and metabolism
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	2014 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 03 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	2014 Year 02 Month 03 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015225