UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Title of the study (Brief title)	The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-
Region	Japan

Condition
Condition	Nonalcoholic fatty liver disease patients with type 2 diabetes
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main condition of type 2 diabetes is impaired insulin secretion and insulin resistance and to maintain good glycemic control over time, the therapeutic strategies base on the pathology of diabetes is important. Therefore we compare the effect of the SGLT2 inhibitor which is a new type 2 diabetes therapeutic drug with sulfonylurea and thiazolidine. We consider an association between type 2 diabetes and NAFLD and compare the influence of these three kinds of diabetes therapeutic drugs on NAFLD. Besides, we examine the influence of these drugs on beta-cell function during an observation period. This study has possibility to bring important information on making a treatment strategy of type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of liver function and L/S ratio (CT) six months after the intervention
Key secondary outcomes	Change of body weight, visceral fat amount, fasting plasma glucose (FPG), insulin, triacylglycerol (TG), non-esterified fatty acid (NEFA), HDL-cholesterol, LDL-cholesterol, lipoprotein fractionation, adiponectin, hsCPR, TNF-alpha, MCP-, MDA, typIV collagen7S, P-III-P, M2BP, the fibrosis score (NAFLD fibrosis score, FIB-4 index, APRI, BARD score, BAAT score), proinsulin/S-CPR ratio

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dapagliflozin 5mg Sig. 1 or 2 tab po once time a day
Interventions/Control_2	Pioglitazone 15mg Sig. 1 or 2 tab po once time a day
Interventions/Control_3	Glimepiride 0.5 or 1mg Sig. 1 or 3 tab po once or two times a day
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	Nonalcoholic fatty liver disease patients with type 2 diabetes mellitus who visit a hospital for treatment in the outpatient department of the facilities concerned.
Key exclusion criteria	A) Under 20 years old B) Treatment with insulin C) Treatment with SGLT-2 inhibitor, thiazolidinedione or sulfonylurea D) Diabetic coma E) Renal dysfunction (eGFR<45mL/min) F) Cardiac failure G) Viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis H) Infection I) During treatment or treatment plan of malignant neoplasm J) Autoimmune disease K) Use of Steroid medicine and/or immunosuppressor L) Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period M) In addition, when principal investigator or researcher deems inappropriate as a study subject
Target sample size	90

Research contact person
Name of lead principal investigator	Masashi Shimoda
Organization	Kawasaki Medical SchoolKawasaki Medical School
Division name	Division of Diabetes, Endocrinology and Metabolism
Address	Matushima577, Kurashiki, Okayama
TEL	086-462-1111
Email	masashi-s@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Masashi Shimoda
Organization	Kawasaki Medical SchoolKawasaki Medical School
Division name	Devision of Diabetes, Endocrinology and Metabolism
Address	Matushima577, Kurashiki, Okayama
TEL	086-462-1111
Homepage URL
Email	masashi-s@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical SchoolKawasaki Medical School Devision of Diabetes, Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Non profit foundation
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 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 10 Month 19 Day
Last follow-up date	2017 Year 07 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 05 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021576