UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Title of the study (Brief title)	Effects of ipragliflozin on NAFLD in patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes with nonalcoholic fatty liver disease
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effects of ipragliflozin on the hepatic steatosis, visceral/subcutaneous fat volume and glycemic control in type 2 diabetic patients with nonalcoholic fatty liver disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 24
Key secondary outcomes	Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, bodyweight, abdominal visceral adipose tissue, and subcutaneous adipose tissue at week 24.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ipragliflozin 50 mg per day for 24 weeks
Interventions/Control_2	Pioglitazone 15-30 mg per day for 24 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Type 2 diabetic patients 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 22 and lower than 45 kg/m2 4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and thiazolidinedione, and/or insulin therapy at baseline. 5. Patients with NAFLD is suspected by abdominal CT, echo or clinical laboratory tests. 6. Patients who are able to provide written informed consent.
Key exclusion criteria	1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
Target sample size	60

Research contact person
Name of lead principal investigator	Daisuke Ito
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Address	1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL	0493-72-2333
Email	itoven0214@yahoo.co.jp

Public contact
Name of contact person	Daisuke Ito
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Address	1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL	0493-72-2333
Homepage URL
Email	itoven0214@yahoo.co.jp

Sponsor
Institute	Ogawa Red Cross Hospital
Institute
Department

Funding Source
Organization	Ogawa Red Cross Hospital
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 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 21 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 07 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026084