UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017195 |
|---|---|
| Receipt number | R000019950 |
| Scientific Title | Effects for glucose metabolism, body composition, and circulatory dynamics of SGLT2 inhibitor |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2018/08/06 18:27:08 |
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Basic information
Public title
Effects for glucose metabolism, body composition, and circulatory dynamics of SGLT2 inhibitor
Acronym
Pleiotropic effects of SGLT2 inhibitor
Scientific Title
Effects for glucose metabolism, body composition, and circulatory dynamics of SGLT2 inhibitor
Scientific Title:Acronym
Pleiotropic effects of SGLT2 inhibitor
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Solve the pleiotropic effects of SGLT2 inhibitor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of glucose metabolism, incretin secretion, gut peptides secretion, body weight, body composition, and basal metabolic rate.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitor
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with type 2 diabetes. HbA1c: 6.5%~9.0%
Key exclusion criteria
1. The patients with severe macroangiopathy
2. The patients with severe renal and/or liver dysfunction.
3. Women who were pregnant, lactating, or capable of pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-2965
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-2965
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Miyazaki
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 22 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019950
