UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029205 |
|---|---|
| Receipt number | R000033385 |
| Scientific Title | Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2018/09/26 11:24:55 |
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Basic information
Public title
Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Acronym
Effects of Dapagliflozin on Body Composition
Scientific Title
Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Scientific Title:Acronym
Effects of Dapagliflozin on Body Composition
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition including Fat, muscle, and water, in Japanese Type 2 DM
Basic objectives2
Others
Basic objectives -Others
To examine effects of Dapagliflozin, a SGLT2 inhibitor, on Endothelial Function in Japanese Type 2 DM
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Skeletal Muscle Mass
Key secondary outcomes
Changes in Fat mass, water volume, endothelial function, liver fat content, and kidney function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin; 5mg/day
Interventions/Control_2
non-SGLT2 inhibitor treatment for DM
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 DM
HbA1c>7.0%
no history of SGLT2 inhibitor-treatment
patients with on-going diet and exercise therapies
Key exclusion criteria
severe obesity (BMI>35)
Type 1 DM
ketoacidosis
unstable clinical conditions
active infection, liver disease, cancer
eGFR<45
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
seigosugiyama@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
Homepage URL
seigosugiyama@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hispital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
陣内病院 （熊本県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jat/25/6/25_40873/_article
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033385
