UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051350 |
|---|---|
| Receipt number | R000058584 |
| Scientific Title | Efficacy of angiotensin II receptor blocker versus sacubitril valsartan on Blood pressure and glycemic control measured by continuous glucose monitoring in adults with type 2 diabetes complicated by hypertension |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/15 11:43:15 |
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Basic information
Public title
Efficacy of angiotensin II receptor blocker versus sacubitril valsartan on Blood pressure and glycemic control measured by continuous glucose monitoring in adults with type 2 diabetes complicated by hypertension
Acronym
Efficacy of angiotensin II receptor blocker versus sacubitril valsartan on Blood pressure and glycemic control measured by continuous glucose monitoring in adults with type 2 diabetes complicated by hypertension
Scientific Title
Efficacy of angiotensin II receptor blocker versus sacubitril valsartan on Blood pressure and glycemic control measured by continuous glucose monitoring in adults with type 2 diabetes complicated by hypertension
Scientific Title:Acronym
Efficacy of angiotensin II receptor blocker versus sacubitril valsartan on Blood pressure and glycemic control measured by continuous glucose monitoring in adults with type 2 diabetes complicated by hypertension
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of superiority of systolic blood pressure and Time In Range at week 16
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change systolic blood pressure from baseline to week 16
Key secondary outcomes
Proportion of Time In Tight Range at Week 16
Others of Glycemic indicator
Change albuminuria from baseline to week 16
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
angiotensin II receptor blocker
Interventions/Control_2
Sacubitril Valsaltan
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus patients with hypertension over 20 years of age
Patients who have been treated with the maximum dose of angiotensin II receptor blocker
Patients with systolic Blood pressure 135mmHg or more
Patients with HbA1c 6.5% or more and less than 10.5%
Key exclusion criteria
Patients diagnosed with type 1 diabetes
Individuals who have a hypersensitivity to Sacubitril valsartan or angiotensin II receptor blockers
History of angioedema
severe renal dysfunction (eGFR < 30 mL/min/1.73 m2)
severe hepatic dysfunction (Child-Pugh classification C)
pregnant women, or individuals who may be pregnant
other patients who the physician deems unsuitable should avoid using this medication.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasutake |
| Middle name | |
| Last name | Shinohara |
Organization
Tochigi Medical Center Shimotsuga
Division name
Diabetes and Endocrinology
Zip code
329-4498
Address
420-1Kawatsure,Ohira-machi,Tochigi -city,Japan
TEL
0282-22-2551
yasutake@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yasutake |
| Middle name | |
| Last name | Shinohara |
Organization
Tochigi Medical Center Shimotsuga
Division name
Diabetes and Endocrinology
Zip code
32-4498
Address
420-1Kawatsure,Ohira-machi,Tochigi -city,Japan
TEL
0282-22-2551
Homepage URL
yasutale@dokkyomed.ac.jp
Sponsor or person
Institute
Tochigi Medical Center Shimotsuga
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Medical Center Shimotsuga
Address
420-1Kawatsure,Ohira-machi,Tochigi -city,Japan
Tel
0282-22-2551
yasutake@dokkyomed.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
| 2023 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058584
