UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048523 |
|---|---|
| Receipt number | R000055287 |
| Scientific Title | Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD) |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2022/07/30 10:05:48 |
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Basic information
Public title
Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)
Acronym
Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)
Scientific Title
Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym
Effect of tofogliflozin on glycemic fluctuation in patients with type 2 diabetes with non-alcoholic fatty liver disease (NAFLD)
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of SGLT2 inhibitor (tofogliflozin) on glycemic fluctuation in patients with type 2 diabetes with NAFLD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in area under the curve of incremental blood glucose 2 hours after each meal before and after administration of tofogliflozin
Key secondary outcomes
The following degrees of change
Glycoalbumin
Blood glucose level 180 mg / dl or higher, 70-180 mg / dl, time ratio less than 70 mg / dl, blood glucose level less than 54 mg / dl time ratio, nighttime hypoglycemic region time ratio, average blood glucose level, blood glucose standard Deviation, blood glucose fluctuation coefficient, MODD, M value, MAGE, body weight, urinary glucose excretion
Examine the relationship between the above evaluation indicators and the FLI value at baseline (FLI value 30-60, 2 groups of 60 or more, etc.)
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
Tofogliflozin 20 mg once in the morning for 10 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient with Type 2 diabetes with HbA1c level of 7.0 or more and less than 11.0 who were required to be hospitalized for glycemic control
2.Patients with Fatty Liver Index of 30 or higher
3.Patients who drink less than 30g / day for men and 20g / day for women in terms of ethanol
Key exclusion criteria
1.Patients with hypersensitivity to tofogliflozin
2.Patients with contraindications to tofogliflozin
3.Patients with severe renal dysfunction eGFR oh less than 30 or end stage renal disease during dialysis
4.Patients with autoimmune hepatitis, viral liver disease, drug induced fatty liver, primary biliary cirrhosis, and metabolic liver disease
5.Patients who have been treated with SGLT2 inhibitor, GLP1 receptor agonist, and thiazolidine within 3 months before enrollment
6.Patients who the doctor deems inappropriate for participation in this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kumeda |
| Middle name | |
| Last name | Yasuro |
Organization
Minami Osaka Hospital
Division name
Internal medicine
Zip code
5590012
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL
0666850221
y_kumeda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kawaguchi |
| Middle name | |
| Last name | Yuji |
Organization
Minami Osaka Hospital
Division name
Internal medicine
Zip code
5590012
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL
0666850221
Homepage URL
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Institute
Department
Personal name
Funding Source
Organization
Minami Osaka 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
Minami Osaka Hospital
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
Tel
0666850221
y.kawaguchi@minamiosaka.com
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
| 2022 | Year | 08 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055287
