UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Title of the study (Brief title)	Study of the effect of tofogliflozin on glucose and lipid metabolism abnormality after the test meal loading.
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the effect and safety of tofogliflozin on glucose and lipid metabolism after test meal loading in male patient with type II diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in postprandial area under curve of serum triglycerides from baseline to 8week drug treatment to 8week discontinuation.
Key secondary outcomes	Change in the following items from baseline to 8week drug treatment to 8week discontinuation. 1) plasma sample Glucose metabolism, lipid metabolism, electrolyte, hepatic function, atherosclerotic index. 2) urine sample Glucose metabolism, electrolyte, renal function 3) Physical examination Blood pressure, body weight, waist circumference, body mass index, PWV

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	Orally administration of 20 mg tofogliflozin once a day for 8 weeks, and 8 weeks discontinuation
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	75 years-old >
Gender	Male
Key inclusion criteria	The male patients with type II diabetes mellitus. 1) Age range from 20 to 74 2) Glycated hemoglobin less than 9.0 %
Key exclusion criteria	1) Patient who had SGLT2 inhibitor with past 2 months. 2) Patient whose concomitant drug had changed with past 2 months. 3) Patient who is diagnosed as contraindication of tofogliflozin. (1) Patient with a history of hypersensitivity to any of the components of the product (2) Patient with a severe ketotic diabetic coma or precoma. (3) Patient with severe infectious disease, before and after operation, and a serious injury. 4) Patient receiving other diabetes drugs. 5) Patient with severe renal disorder (estimated GFR< 30mL/min/1.73m2). 6) Patient with a history of cerebral infarction. 7) Patient receiving diuretic drugs. 8) Patient whom the principle investigator or other investigator consider unsuitable.
Target sample size	10

Research contact person
Name of lead principal investigator	Junji Kobayashi
Organization	Kanazawa Medical University
Division name	Department of General Internal Medicine
Address	Daigaku 1-1 Uchinada Kahoku Ishikawa
TEL	076-218-8352
Email	mary@kanazawa-med.ac.jp

Public contact
Name of contact person	Junji Kobayashi
Organization	Kanazawa Medical University
Division name	Department of General Internal Medicine
Address	Daigaku 1-1 Uchinada Kahoku Ishikawa
TEL	076-218-8352
Homepage URL
Email	mary@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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

Other related organizations
Co-sponsor	Kakuda Clinic
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	2014 Year 11 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 07 Day
Anticipated trial start date	2014 Year 10 Month 25 Day
Last follow-up date	2015 Year 06 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018363