![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
Name | UMIN ID |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000020615 |
Receipt No. | 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 |
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 |
|
Condition | ||||
Condition | Patients of type 2 diabetes mellitus with nonalcoholic fatty liver disease (NAFLD). | |||
Classification by specialty |
|
|||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
Institute | Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine. |
Institute | |
Department |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | 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 | |
Registered date | File name |
Research case data | |
Registered date | File name |