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

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 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


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

Value
https://center6.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