UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040611
Receipt number R000046345
Scientific Title Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Date of disclosure of the study information 2020/06/01
Last modified on 2022/10/29 06:26:05

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Basic information

Public title

Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes

Acronym

Long-term effects of ipragliflozin on NAFLD in patients with type 2 diabetes

Scientific Title

Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes

Scientific Title:Acronym

Long-term effects of ipragliflozin on NAFLD in patients with type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes complicated by NAFLD

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 long-term effects of ipragliflozin on the hepatic steatosis, visceral/subcutaneous fat volume and glycemic control in patients with type 2 diabetes complicated by NAFLD.

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 5 years

Key secondary outcomes

Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, adiponectin, body weight, abdominal visceral adipose tissue, and subcutaneous adipose tissue at 5 years.


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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Type 2 diabetic patients
2. HbA1c higher than 7.0% and lower than 11.0%
3. BMI 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

1st name Daisuke
Middle name
Last name Ito

Organization

Ogawa Red Cross Hospital

Division name

Department of Internal Medicine

Zip code

355-0397

Address

1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan

TEL

0493-72-2333

Email

dito@saitama-med.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ito

Organization

Ogawa Red Cross Hospital

Division name

Department of Internal Medicine

Zip code

355-0397

Address

1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan

TEL

0493-72-2333

Homepage URL


Email

dito@saitama-med.ac.jp


Sponsor or person

Institute

Ogawa Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Ogawa Red Cross Hospital

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

Ogawa Red Cross Hospital

Address

1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan

Tel

0493-72-2333

Email

dito@saitama-med.ac.jp


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

2020 Year 06 Month 01 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

66

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Because it takes time to collect and analyze data.

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

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB

2020 Year 05 Month 08 Day

Anticipated trial start date

2015 Year 03 Month 21 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ipragliflozin 50 mg per day or pioglitazone 15-30 mg per day for 24 weeks.
After intervention therapy, patients returned to hospital based diabetes care according to their clinical needs.


Management information

Registered date

2020 Year 06 Month 01 Day

Last modified on

2022 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046345


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name