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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041326
Receipt No. R000047186
Scientific Title Effect of Esaxerenone, a novel mineralocorticoid receptor antagonist on insulin resistance in diabetic patients with hypertension.
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/05

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Basic information
Public title Effect of Esaxerenone, a novel mineralocorticoid receptor antagonist on insulin resistance in diabetic patients with hypertension.
Acronym Effect of Esaxerenone, a novel mineralocorticoid receptor antagonist on insulin resistance in diabetic patients with hypertension.
Scientific Title Effect of Esaxerenone, a novel mineralocorticoid receptor antagonist on insulin resistance in diabetic patients with hypertension.
Scientific Title:Acronym Effect of Esaxerenone, a novel mineralocorticoid receptor antagonist on insulin resistance in diabetic patients with hypertension.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of Esaxerenone on insulin resistance in type 2 diabetic patients with hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in M/I ratio from baseline at 6 months
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esaxerenone
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 Outpatients with type 2 diabetes and hypertension, who are treated with ACE inhibitor or angiotensin II receptor blocker.
Key exclusion criteria 1. Patients treated with insulin
2. Patients treated with steroid
3. Patients with renal disfunction(eGFR<60)
4. Patients with hyperkalemia(K>5.0mEq/L)
5. Pregnant or nursing patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Araki
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code 860-8556
Address 1-1-1 Honjo Chuo-ku Kumamoto
TEL 0963735169
Email earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Motoyuki
Middle name
Last name Igata
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code 860-8556
Address 1-1-1 Honjo Chuo-ku Kumamoto
TEL 0963735169
Homepage URL
Email iga@gpo.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Self funding
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 Kumamoto university independent ethics committee
Address 1-1-1 Honjo Chuo-ku Kumamoto
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-u.ac.jp

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
2020 Year 09 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
2020 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 05 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047186

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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