UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041326 |
|---|---|
| Receipt number | 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 16:46:48 |
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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
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
iga@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047186
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
