UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000029697
Receipt number	R000033941
Scientific Title	Examination of efficacy of selective sodium-glucose cotransporter-2 inhibitor (SGLT2I) for patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease / nonalcoholic steatohepatitis
Date of disclosure of the study information	2017/10/24
Last modified on	2018/10/28 21:51:49

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Basic information

Public title

Examination of efficacy of selective sodium-glucose cotransporter-2 inhibitor (SGLT2I) for patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease / nonalcoholic steatohepatitis

Acronym

Efficacy of SGLT2I on NAFLD/ NASH

Scientific Title

Scientific Title:Acronym

Efficacy of SGLT2I on NAFLD/ NASH

Region

Japan

Condition

Type 2 diabetes mellitus Nonalcoholic fatty liver disease

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The aim of this study is to identify the efficacy of SGLT2I for NAFLD.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

1. Identify change of liver enzyme and steatosis using biochemical measurements and ultrasonography after 24 weeks.

Key secondary outcomes

Identify change of HbA1c, cytokine, adipokine, type 4 collagen 7S, and insulin after 24 weeks.

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Not applicable

Gender

Male and Female

Key inclusion criteria

body mass index (BMI) > 22 kg/m2
hemoglobin A1c (HbA1c) > 6.5%.

Key exclusion criteria

decompensated liver cirrhosis
hepatocellular carcinoma, or extrahepatic cancer
serum creatinine level < 2.0 mg/dL
pregnancy or lactation

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yoichi Hiasa

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

Address

Toon City, Ehime, Japan

TEL

+81899605308

Email

teruki-ygc@umin.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Teruki Miyake

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

Address

Toon city, Ehime

TEL

+81899605308

Homepage URL

Email

teruki-ygc@umin.ac.jp

Sponsor or person

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 24 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://www.degruyter.com/view/j/med

Number of participants that the trial has enrolled

Results

Forty-three patients with T2DM and NAFLD were enrolled (12 with biopsy-proven NASH and 31 with NAFLD diagnosed by ultrasonography). After 24 weeks, body weight, hemoglobin A1c (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, body fat mass, and steatosis were significantly decreased compared to baseline measurements in patients with NASH. However, muscle mass was not reduced, and liver stiffness showed a statistically insignificant tendency to decrease. NAFLD patients also showed a significant reduction in body weight, HbA1c, AST, and ALT compared to baseline measurements.

Results date posted

Results Delayed

Results Delay Reason

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 11 Month 01 Day

Date of IRB

Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2017 Year 06 Month 30 Day

Date of closure to data entry

2017 Year 07 Month 30 Day

Date trial data considered complete

2017 Year 07 Month 30 Day

Date analysis concluded

2017 Year 08 Month 30 Day

Other

Other related information

Patients received oral ipragliflozin (50 mg/day) once daily for 24 weeks. We recorded the results of physical examinations and routine biochemical studies. Body composition was evaluated using InBody720, and the controlled attenuation parameter for the quantification of liver steatosis and liver stiffness was measured by transient elastography in patients with NASH. We compared pre- and post-treatment continuous variables.

Management information

Registered date

2017 Year 10 Month 24 Day

Last modified on

2018 Year 10 Month 28 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033941

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name