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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040611
Receipt No. 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 2020/06/07

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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
Institute Ogawa Red Cross Hospital
Institute
Department

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
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 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
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.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


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