UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048598
Receipt No. R000055372
Scientific Title Non-inferior Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
Date of disclosure of the study information 2022/08/06
Last modified on 2022/08/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Non-inferior Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
Acronym FERRET
Scientific Title Non-inferior Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
Scientific Title:Acronym FERRET
Region
Japan

Condition
Condition hypertension, type2 daibetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish evidence for the effects of sacubitril valsartan on glucose metabolism and other metabolic parameters, in addition to examining non-inferiority of sacubitril valsartan on antihypertensive effects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Systolic blood pressure variation in two groups at 24 weeks after test drug administration.
Key secondary outcomes Heart rate, blood test(AST, ALT, BUN, Creatinin, NT-proBNP, eGFR, renin/aldosteron ratio), urine albumin, fast blood glucose, HbA1c, insulin, C-peptide release, Inbody-analysis, hypotension, hypoglycemic symptoms, drug rash at12and 24weeks after drug administration.

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
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sacubitril-Valsartan 200mg once daily for 24weeks.
Interventions/Control_2 Azilsartan 20mg once daily for 24weeks.
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 (1) Patients over 20 years old with type 2 diabetes mellitus and hypertension
(2) Patients using Semaglutide (oral or injectable formulation) at the time of study entry
(3) Patients with HbA1c (NGSP) between 6.5% and 10%.
(4) Patients on treatment for hypertension who have not used ARBs for at least the past 2 weeks and whose systolic blood pressure is 140 mmHg or higher
(5) Patients who have had the study explained to them in writing and who have given written consent to participate in the study.
Key exclusion criteria (1) Patients with HbA1c (NGSP) less than 6.5% or greater than 10% at the start of the study
(2) Patients with systolic blood pressure less than 140 mmHg
(3) Patients who are incapable of adequate understanding or cooperation due to mental dysfunction, uncooperative participation, or language barriers
(4) Patients with a history of hypersensitivity to Azilsartan, valsartan, or sacubitril valsartan
(5) Pregnant women or patients who may be or are planning to become pregnant
(6) Patients using Aliskiren-fumarate
(7) Patients with a history of angioedema
(8) Patients with bilateral renal artery stenosis
(9) Patients with severe hepatic impairment (Child-Pugh classification C)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryoichi
Middle name
Last name Ishibashi
Organization Kimitsu Chuo Hospital
Division name Department of medicine Division of Diabetes, Endocrionology and Metabolism
Zip code 2928535
Address 1010 Sakurai Kisarazu Chiba
TEL 0438361071
Email ishibashi-cib@umin.net

Public contact
Name of contact person
1st name Ryoichi
Middle name
Last name Ishibashi
Organization Kimitsu Chuo Hospital
Division name Department of medicine Division of Diabetes, Endocrionology and Metabolism
Zip code 29288535
Address 1010 Sakurai Kisarazu Chiba
TEL 0438361071
Homepage URL
Email ishibashi-cib@umin.net

Sponsor
Institute Kimitsu Chuo Hospital
Institute
Department

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 Kimitsu Chuo Hospital
Address 1010 Sakurai Kisarazu Chiba
Tel 0438361071
Email ishibashi-cib@umin.net

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
2022 Year 08 Month 06 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
2022 Year 06 Month 18 Day
Date of IRB
2022 Year 07 Month 19 Day
Anticipated trial start date
2022 Year 08 Month 05 Day
Last follow-up date
2024 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
2022 Year 08 Month 05 Day
Last modified on
2022 Year 08 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.