Unique ID issued by UMIN | UMIN000048598 |
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Receipt number | 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 | 2022/10/17 17:29:21 |
Non-inferiority trial of Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
FERRET
Non-inferior Anti-hypertnsive Effect of Sacubitril-Valsartan to Azilsartan In Pateints With Type 2 Daibetes Mellitus Treated With Semaglutide
FERRET
Japan |
hypertension, type2 daibetes mellitus
Cardiology | Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Not applicable
Systolic blood pressure variation in two groups at 24 weeks after test drug administration.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Sacubitril-Valsartan 200mg once daily for 24weeks.
Azilsartan 20mg once daily for 24weeks.
20 | years-old | <= |
Not applicable |
Male and Female
(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.
(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)
60
1st name | Ryoichi |
Middle name | |
Last name | Ishibashi |
Kimitsu Chuo Hospital
Department of medicine Division of Diabetes, Endocrionology and Metabolism
2928535
1010 Sakurai Kisarazu Chiba
0438361071
ishibashi-cib@umin.net
1st name | Ryoichi |
Middle name | |
Last name | Ishibashi |
Kimitsu Chuo Hospital
Department of medicine Division of Diabetes, Endocrionology and Metabolism
29288535
1010 Sakurai Kisarazu Chiba
0438361071
ishibashi-cib@umin.net
Kimitsu Chuo Hospital
None
Self funding
Kimitsu Chuo Hospital
1010 Sakurai Kisarazu Chiba
0438361071
ishibashi-cib@umin.net
NO
2022 | Year | 08 | Month | 06 | Day |
Unpublished
Open public recruiting
2022 | Year | 06 | Month | 18 | Day |
2022 | Year | 07 | Month | 19 | Day |
2022 | Year | 10 | Month | 17 | Day |
2024 | Year | 03 | Month | 31 | Day |
2022 | Year | 08 | Month | 05 | Day |
2022 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055372
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