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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017195
Receipt No. 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

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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
Email 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
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019950

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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