UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin
Title of the study (Brief title)	Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the relationship between changes in body weight during the early phase of treatment with tofogliflozin and dehydration during the middle phase of the treatment, in patients with type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between changes in body weight at Week 2 of treatment and the frequency of deviations from upper limit reference values for hematocrit at Week 24
Key secondary outcomes	(1) Safety: frequency of adverse effects and adverse events (events, severity, incidence rates, etc.) (2) Efficacy: changes over time in the parameters listed below. HbA1c (NGSP value), blood sugar, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglycerides, BUN, serum creatinine, uric acid, body weight, blood pressure, hematocrit. (3) Others changes from baseline in HbA1c, body weight, hematocrit, lipid, uric acid, and frequency of adverse events, etc. in tofogliflozin-treated patients after stratification based on baseline values

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	From baseline to Week 24, patients will receive oral tofogliflozin at a dose of 20 mg per administration, once daily, either before or after breakfast.
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) Patients diagnosed with diabetes mellitus (2) Patients aged 20 years of age or more (3) Patients who have no prior history of using SGLT2 inhibitors (4) Patients who provide written informed consent to participate in this clinical study
Key exclusion criteria	(1) Patients with a prior history of hypersensitivity to any of the ingredients of tofogliflozin (2) Patients with severe ketosis, diabetic coma, or precoma (3) Patients with severe infections or severe injuries or those who are scheduled to receive or have received surgical treatment (4) Patients with severe hepatic function impairment (5) Patients with end-term renal failure who are on hemodialysis or peritoneal dialysis (6) Patients who are determined by principal investigators or sub-investigators to be ineligible for the clinical study
Target sample size	200

Research contact person
Name of lead principal investigator	Masahiro Sugawara
Organization	General incorporated Tokyo Physicians Association
Division name	Chairman
Address	Sumitomo Corporation Takebashi BLDG 13F,1-2-2 Hitotsubashi, Chiyoda-ku, Tokyo, Japan
TEL	03-6256-0414
Email	topa@proof.ocn.ne.jp

Public contact
Name of contact person	Clinical Study Support Center
Organization	Satt Co., Ltd.
Division name	Promotion division of the clinical study
Address	Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-5312-5026
Homepage URL
Email	sweat@sa-tt.co.jp

Sponsor
Institute	General incorporated Tokyo Physicians Association
Institute
Department

Funding Source
Organization	Kowa Company, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 04 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 24 Day
Anticipated trial start date	2015 Year 04 Month 13 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 07 Day
Last modified on	2017 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019787