UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020615 |
|---|---|
| Receipt number | R000023342 |
| Scientific Title | Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD). |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2017/07/21 11:28:26 |
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Basic information
Public title
Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD).
Acronym
SGLT2 Inhibitor for T2DM with NAFLD.
Scientific Title
Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD).
Scientific Title:Acronym
SGLT2 Inhibitor for T2DM with NAFLD.
Region
| Japan |
Condition
Condition
Patients of type 2 diabetes mellitus with nonalcoholic fatty liver disease (NAFLD).
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of adding canagliflozin, an inhibitor of sodium-glucose cotransporter 2,in patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease(NAFLD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hepatic fat fraction (HFF) by hepatic magnetic resonance imaging (MRI) after 6 or 12 months.
Key secondary outcomes
body weight, HbA1c, glucagon, type IV collagen, hyaluronic acid and NAFLD fibrosis score.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
canagliflozin100mg/day
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 diabetes
2: Patients with NAFLD diagnosed by clinical data
3: Patients provided with informed consent
Key exclusion criteria
1: Diabetic ketoacidosis and hyperosmolar hyperglycemic state
2: Insulin dependent diabetes
3: Before and after surgery and severe trauma
4: Taking excessive alcohol
5: Severe renal failure or undergoing hemodialysis
6: Proliferative diabetic retinopathy
7: Obvious orthostatic hypotension
8: Patient who cannot be ruled out other liver disease including viral hepatitis, autoimmune hepatitis, a drug-induced hepatitis.
9: Severe hepatic dysfunction
10: Malignant neoplasm
11: Women who have a possibility of pregnancy or is pregnant
12: Allergy to SGLT2 inhibitors, having a recent history of taking SGLT2 inhibitors
13: Patient who is suspected type 1 diabetes and other diabetes
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuko Inoue |
Organization
Kitasato University School of Medicine.
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
mitsuko_oku325@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuko Inoue |
Organization
Kitasato University School of Medicine.
Division name
Department of Endocrinology, Diabetes and Metabolism.
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan.
TEL
042-778-8111
Homepage URL
mitsuko_oku325@yahoo.co.jp
Sponsor or person
Institute
Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
nothing
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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | 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 | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023342
| 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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