UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029167 |
|---|---|
| Receipt number | 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 23:13:45 |
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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
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
tounai@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033348
