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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029167
Receipt No. R000033348
Scientific Title Switching from low dose thiazide diuretics to SGLT2 inhibitor in subjects with type 2 diabetes and hypertension
Date of disclosure of the study information 2017/09/16
Last modified on 2017/09/15

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Basic information
Public title Switching from low dose thiazide diuretics to SGLT2 inhibitor in subjects with type 2 diabetes and hypertension
Acronym Switching from low dose thiazide diuretics to SGLT2 inhibitor in type 2 diabetes patients
Scientific Title Switching from low dose thiazide diuretics to SGLT2 inhibitor in subjects with type 2 diabetes and hypertension
Scientific Title:Acronym Switching from low dose thiazide diuretics to SGLT2 inhibitor in type 2 diabetes patients
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to compare the effects of SGLT2 inhibitor and thiazide diuretic on blood pressure, metabolic parameters and body mass composition.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, HbA1c
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria HbA1c > 6.0%, having already taken thiazide diuretics for hypertension with ARB or ACE-I, and/or CCB in subjects with type 2 diabetes.
Key exclusion criteria (1) without severe renal dysfunction, (2) without severe liver dysfunction, (3) without infectious disease, malignancy or various endocrine diseases and (4) not using steroid drug.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Kimura
Organization kawasaki Medical School
Division name Division of Diabetes, Endocrinology and Metabolism
Zip code
Address Matsushima 577, Kurashiki 701-0192, Japan
TEL 086-462-1111
Email tomohiko@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Kimura
Organization kawasaki Medical School
Division name Division of Diabetes, Endocrinology and Metabolism
Zip code
Address Matsushima 577, Kurashiki 701-0192
TEL 086-462-1111
Homepage URL
Email tounai@med.kawasaki-m.ac.jp

Sponsor
Institute kawasaki Medical School
Institute
Department

Funding Source
Organization none
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
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
2017 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Switching from low dose thiazide diuretics to SGLT2 inhibitor improves various metabolic parameters without affecting
blood pressure in subjects with type 2 diabetes and hypertension

Management information
Registered date
2017 Year 09 Month 15 Day
Last modified on
2017 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033348

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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