diabetes mellitus
Conditions
Interventions
Olmesartan treatment group (Group O)
Clinical investigators will initiate olmesartan (20mg/day) treatment following the allocation in the olmesartan treatment group. Treatment will be continued to achieve the target value specified in th
130/85 mmHg).
Amlodipine treatment group (Group A)
Clinical investigators will initiate amlodipine (5mg/day) treatment following the allocation in the amlodipine treatment group. Treatment will be continued to achieve the target value specified in the
130/85 mmHg).
Sponsors
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Type 2 diabetes patients (HbA1c (JDS value) below 8.0%) treated with dietary/exercise therapy and/or alpha-glucosidase inhibitors or nateglinide. 2) Having hypertension 3) aged 30 to 75 years of age at the time of enrollment (regardless of gender) 4) Written consent for participation in the study
Exclusion criteria
Exclusion criteria: Patients meeting one of the following conditions will be excluded: 1) unable to visit the outpatient clinics of diabetes periodically 2) diabetic retinopathy 3) advanced (≥ stage 4) diabetic nephropathy 4) severe hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg 5) diagnosed as having malignancy within 5 years 6) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study were 1)Achievement rate of targeted blood pressure (<130/85mmHg) during a 24-week treatment period 2)Improvement rate of fasting blood glucose and HbA1c levels during a 24-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints were 1) Changes in the IMT value (mean and max IMT) during a 24-week treatment period measured by carotid arterial echography 2) Changes in the serum esRAGE levels during a 24-week treatment period 3) Changes in the insulin secretion and insulin resistance during a 24-week treatment period 4) Changes in the urinary albumin excretion rates during a 24-week treatment period | — |
Countries
Japan
Outcome results
None listed