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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015402
Receipt No. R000017913
Scientific Title Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Date of disclosure of the study information 2014/11/01
Last modified on 2014/10/10

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Basic information
Public title Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Acronym Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Scientific Title Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Scientific Title:Acronym Effects of a SGLT2 inhibitor on glucose metabolism and body composition in patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To collectively evaluate the effects of a SGLT2 inhibitor on patients assessing glucose metabolism, body weight, food consumption and composition, physical activity, body composition over time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c, fasting plasma glucose, insulin, body weight, fat mass, lean body mass, food consumption
Key secondary outcomes serum osmolality, urine osmolality, blood urea nitrogen, serum creatinine, LDL cholesterol, HDL cholesterol, triglyceride, free fatty acid, GOT, GPT, glucagon, GLP-1

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients with type 2 diabetes mellitus
2.HbA1c 7.0-10.0%
3.Patients who have received anti-diabetics without any change over at least 3 months
4.The change in body weight is 2 kg or less and that of HbA1c is 0.5% or less over at least 3 months
5.Patients who provided written informed consent
Key exclusion criteria 1.Serious infection
2.Serious liver and/or kidney disease
3.End stage renal disease with undergoing hemodialysis or peritoneal dialysis
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshio Iwakura
Organization Kobe City Medical Center General Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-1-2, Minatojimaminamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan
TEL 078-302-4321
Email iwakura@kcho.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshio Iwakura
Organization Kobe City Medical Center General Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-1-2, Minatojimaminamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan
TEL 078-302-4321
Homepage URL
Email iwakura@kcho.jp

Sponsor
Institute Department of Diabetes and Endocrinology
Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Department of Diabetes and Endocrinology
Kobe City Medical Center General Hospital
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 神戸市立医療センター中央市民病院

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2015 Year 10 Month 01 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 10 Month 31 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information prospective study

Management information
Registered date
2014 Year 10 Month 10 Day
Last modified on
2014 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017913

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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