UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, controlled trial of the clinical effect of selecrive SGLT2 blocker, ipragliflozin, and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.- multicenter study -
Acronym	Randomized, controlled trial of ipragliflozin and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Scientific Title	Randomized, controlled trial of the clinical effect of selecrive SGLT2 blocker, ipragliflozin, and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.- multicenter study -
Scientific Title:Acronym	Randomized, controlled trial of ipragliflozin and DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Region	Japan

Condition
Condition	type 2 diabetic patients with NAFLD/NASH
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of whether glycemic control is improved by ipragliflozin or DPP-4 blocker in type 2 diabetic patients with NAFLD/NASH.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of patients decreasing of HbA1c>0.5% and not gaining weight gain 72 weeks after administration.
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	dietand ergotherapy and or (alpa-GI, Met) and sugra.
Interventions/Control_2	diet and ergotherapy and/or (alpa-GI,Met) +DPP-4 blocker.
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	1.Diet and exercise therapy plus or minus oral diabetes agent therapy, for example a-GI or metformin, for more than 12 weeks. The condition is the following HbA1c is more than 6.5 2.Patients with NASH or NAFLD diagnosed by using the guideline defined by JGH 3.Age is no fewer than 80, nor more than 20 4.Sex is female or male 5.Consenting patients
Key exclusion criteria	1.Ppatients with diabetes 2.Patients with past history of ovascular lesion or stroke 3.Patients with past history of allergy 4.Patients with the necessity of IRI therapy 5.Patients with past history of liver disorder or renal dysfunction 6.Inadequacy of usingig this therapy
Target sample size	128

Research contact person
Name of lead principal investigator	1st name Keizo Middle name Last name Anzai
Organization	Saga University
Division name	internal Medicine
Zip code	8498501
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2362
Email	akeizo0479@gmail.com

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Takahashi
Organization	Saga University
Division name	internal Medicine
Zip code	8498501
Address	5-1-1 Nabeshima, Saga
TEL	0952-.34-2362
Homepage URL
Email	takahas2@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	clinical research center, saga university hospital
Address	5-1-1 Nabesima, Saga
Tel	0952343400
Email	@

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 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	55
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	This study corresponded to Specified Clinical Research and result will be open on jRCT.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 13 Day
Date of IRB	2014 Year 08 Month 13 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information	This study corresponded to Specified Clinical Research and detailed information was registered with jRCT.

Management information
Registered date	2014 Year 11 Month 20 Day
Last modified on	2020 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018010