UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Dapagliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized,Open-Label, Active-Controlled Trial
Title of the study (Brief title)	Comparison of Dapagliflozin and Pioglitazone Effects on NAFLD and NASH in Patients With Type 2 Diabetes: A Randomized Trial
Region	Japan

Condition
Condition	type 2 diabetes mellitus, NAFLD, NASH
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects between dapagliflozin and pioglitazone on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c, hepatic attenuation compared with spleen on CT scan imaging
Key secondary outcomes

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	Dapagliflozin 5 mg/day, 104 weeks
Interventions/Control_2	Pioglitazone 15-30 mg/day, 104 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	HbA1c= or > 6.5%
Key exclusion criteria	Patients with diabetes complications
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Mochida
Organization	Saitama Medical University
Division name	Department of gastroenterology and hepatology
Address	38 Morohongo, Moroyamamachi
TEL	049-276-1111
Email	smochida@saitama-med.ac.jp

Public contact
Name of contact person	Nobuaki Nakayama
Organization	Saitama Medical University
Division name	Department of gastroenterology and hepatology
Address	38 Morohongo, Moroyamamachi
TEL	049-276-1111
Homepage URL
Email	nobunaka@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama 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	2017 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 14 Day
Anticipated trial start date	2015 Year 09 Month 14 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	2017 Year 12 Month 24 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034855