UMIN-CTR Clinical Trial

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
Email	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
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minami Osaka Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055287