UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020086 |
|---|---|
| Receipt number | 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 15:01:11 |
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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
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
nokaya@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023197
