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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020086
Receipt No. R000023197
Scientific Title The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes
Date of disclosure of the study information 2015/12/14
Last modified on 2016/02/25

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Basic information
Public title The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes
Acronym Study for the relation between a SGLT2 inhibitor and the hormones regulating appetite
Scientific Title The multicenter clinical study of the relation between a SGLT2 inhibitor and the hormones regulating appetite in the patients with type 2 diabetes
Scientific Title:Acronym Study for the relation between a SGLT2 inhibitor and the hormones regulating appetite
Region
Japan

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

Objectives
Narrative objectives1 To clarify the relation between a SGLT2 inhibitor (Canagliflozin) and the changes of hormones regulating appetite
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of the hormones regulating appetite (active ghrelin and PYY) after 12 weeks from start of administrating of Canagliflozin
Key secondary outcomes

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 Oral administration of 100 mg Canagliflozin once a day after breakfast for 24 weeks
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients under diet therapy and exercise
2. Patients without medicine or with under 2 types of diabetic medicines for 2 months except for an another SGLT2 inhibitor
3. HbA1c (NGSP) over 7.0 % or under 10 %
4. Patients who can understand the study and agree with the study by the document
Key exclusion criteria 1. Patients with an allergy to Canagliflozin
2. Patients with diabetic ketoacidosis, diabetic coma and type 1 diabetes
3. Patients with over 2 times from upper limit of normal ranges of AST, ALT, or gamma-GTP
4. Patients with under 45 ml/min/1.73m2 of eGFR
5. Patients with severe inflammation or injury, or before or after operation
6. Patients with cancer or inflammatory bowel disease, or after operation of GI tracts
7. Patients with pregnancy or during lactation
8. Patients who are thought to be unsuitable for the study by the attending doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naotsuka Okayama
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8211
Email nokaya@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naotsuka Okayama
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8211
Homepage URL
Email nokaya@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya City East Medical Center
Nagoya City West Medical Center
Kariya Toyota General Hospital
Chita Kosei Hospital
Asahi Rousai Hospital
Toyokawa City Hospital
Nishitita General Hospital
Takahashi Family Clinic
Okouchi Internal Medicine Clinic
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 名古屋市立大学病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋市立西部医療センター(愛知県)、刈谷豊田総合病院(愛知県)、愛知県厚生連知多厚生病院(愛知県)、旭労災病院(愛知県)、豊川市民病院(愛知県)、公立西知多総合病院(愛知県)、高橋ファミリークリニック(愛知県)、おおこうち内科クリニック(愛知県)、

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 14 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 06 Day
Last modified on
2016 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023197

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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