UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Acronym	Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Scientific Title	Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Scientific Title:Acronym	Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tofogliflozin is a drug with high protein binding rate and short half-life in blood. On the other hand, Ipragliflozin is a drug having a low protein binding rate and a long half life in blood. These two agents contrast in-vivo pharmacokinetics, and compare the effects on blood glucose fluctuation to examine the usefulness of SGLT2 inhibitors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of time less than 70 mg/dl (low blood glucose area) of continuous glucose monitoring (CGM)
Key secondary outcomes	The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), euglycemic area (70-179 mg/dl), hypoglycemic area (less than 70 mg/dl), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in CGM. Nighttime average blood glucose (0:00-5:59), daytime average blood glucose (6:00-23:59), blood glucose level 2 hours after every meal, 24-hour average blood glucose level, SD value, CV value, daily variation , M value, MAGE, urine glucose (0:00-7:30, 7:30-23:59), urine volume (0:00-7:30, 7:30-23:59).

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tofogliflozin-Ipragliflozin group
Interventions/Control_2	Ipragliflozin-Tofogliflozin group
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.target age 20 years old or older under 75 years old. 2.Patients who have been diagnosed with type 2 diabetes for more than 1 year before starting the trial. 3.Basal supported oral therapy with insulin glargine U-300 from over 3 months ago. 4.Patients who are treating glycated hemoglobin (HbA1c) levels 7.0% or more and less than 10.5%. 5.Patients with body mass index (BMI) 20.0kg/m2 or more 45.0kg / m2 or less. 6.Patient with estimated glomerular filtration rate (eGFR) 45 mL/min/1.73 m2 or more.
Key exclusion criteria	1.Patients who have a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of study start. 2.Patients who developed severe hypoglycemia (diabetic coma or pre-coma, convulsions, etc. require assistance by a third party) within 6 weeks of study start. 3.Patients who have a history of medically important renal diseases such as renal vascular occlusive disease, nephrectomy and renal transplantation. 4.Patients who show symptoms of dysuria, anuria, oliguria or urinary retention 5.Patients who developed urinary tract infections and genital infections with subjective symptoms within 6 weeks of the study start. 6. Patients with proliferative retinopathy (however, patients with photocoagulation etc. who have stable symptoms can be included). 7. Patients with severe gastrointestinal disorders within 2 weeks of the study, or patients with a history of severe gastrointestinal disorders. 8.Patients with acute coronary syndrome, cerebrovascular disorder within 3 months. 9. Women and lactating patients who may or may be pregnant. 10. Patients with severe infections, before and after surgery, with serious trauma. 11. Patients receiving systemic administration of corticosteroids. 12.Patients who have severe liver dysfunction (a high level of AST or ALT of at least 100 U / L). 13.Patients who have a history of allergies to the drugs intended for the study. 14. Patients with a malignant tumor or a history of malignant tumor. 15.Patients judged by the investigator as inappropriate as subjects.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal Medicine
Zip code	559-0012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka 559-0012, Japan
TEL	0666850221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	1st name Yuji Middle name Last name Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal Medicine
Zip code	559-0012
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	nothing
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	2019 Year 06 Month 26 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	Completed
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2019 Year 01 Month 10 Day
Anticipated trial start date	2019 Year 06 Month 26 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
Date trial data considered complete	2020 Year 05 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 06 Month 25 Day
Last modified on	2020 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042340