hypertension, type2 daibetes mellitus
Conditions
Interventions
Sacubitril-Valsartan 200mg once daily for 24weeks.
Azilsartan 20mg once daily for 24weeks.
Sponsors
Kimitsu Chuo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure variation in two groups at 24 weeks after test drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactRyoichi Ishibashi
Kimitsu Chuo Hospital Department of medicine Division of Diabetes, Endocrionology and Metabolism
Outcome results
None listed