UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus
Acronym	AYUMI
Scientific Title	Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus
Scientific Title:Acronym	AYUMI
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 investigate the safety and efficacy of tofogliflozin under usual care
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following side effects:events, grades, occurrence rates, etc *Hypoglycemia *Urinary tract infection and Genital infection *Volume depletion (Dehydration, Polyuria/Pollakiuria, Hypotension) *Diabetic ketoacidosis *Renal dysfunction *Hepatic dysfunction *Fracture *Malignant tumor *Major adverse cerebro-cardiovascular events *Skin disorders
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with Type 2 diabetes mellitus 2.Receiving tofogliflozin under usual care within 8 weeks before registration 3.Aged 20 and over 4.No use of SGLT2 inhibitor before tofogliflozin
Key exclusion criteria	1.Hypersensitivity to tofogliflozin 2.Patients who had severe ketosis or diabetic coma or precoma 3.Severe infection or trauma, perioperative 4.End stage renal disease with hemodialysis or peritoneal dialysis 5.Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichiro Yamada
Organization	Japan Association for Diabetes Education and Care
Division name	Academic commitee
Zip code
Address	2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan
TEL	03-3514-1721
Email	yamada@gipc.akita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuyuki Shihara
Organization	Japan Association for Diabetes Education and Care
Division name	secretariat
Zip code
Address	2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan
TEL	03-3514-1721
Homepage URL	http://www.nittokyo.or.jp/about/research/report/detail.php?t=1&p=13
Email	shihara@nittokyo.or.jp

Sponsor
Institute	Japan Association for Diabetes Education and Care
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 05 Month 31 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	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A survey of commercially available drugs performed by physicians on a voluntary basis

Management information
Registered date	2014 Year 05 Month 31 Day
Last modified on	2018 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016419

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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