UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022651 |
|---|---|
| Receipt number | R000026084 |
| Scientific Title | Effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/06/07 |
| Last modified on | 2018/05/14 23:08:12 |
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Basic information
Public title
Effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Acronym
Effects of ipragliflozin on NAFLD in patients with type 2 diabetes
Scientific Title
Effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL
0493-72-2333
itoven0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL
0493-72-2333
Homepage URL
itoven0214@yahoo.co.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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026084
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
