Type 2 DM complicated with high blood pressure
Conditions
Interventions
Group A: Administer dapagliflozin Dapagliflozin is administered in addition to oral hypoglycemic agents that are in-use at the time of registration to this study, and continue to the week 24. Dapag
Sponsors
The Japan Society for Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Type 2 diabetic patients with HbA1c 7.0% to 9.0% 2. Patients who have been taking 1-3 different antidiabetic agents (oral hypoglycemic drugs) for at least12 weeks before consenting to study participation 3. Patients who were 20-year old or older, and younger than 80-year old at the time of consent 4. Patients with stage-I hypertension (early morning systolic blood pressure measured at home is 135 mmHg or higher and below 155 mmHg, or systolic blood pressure measured at office is 140 mmHg or higher and below 160 mmHg), stage-II hypertension (early morning systolic blood pressure measured at home is 155 mmHg or higher and below 175 mmHg, or systolic blood pressure measured at office is 160 mmHg or higher and below 180 mmHg), or an annually averaged systolic blood pressure measured at office is 140 mmHg or higher and below 160 mmHg, or currently on antihypertensive medication and with ischemic heart disease 5. Patients who can consent in writing
Exclusion criteria
Exclusion criteria: Patients who fall into one or more of the following criteria are excluded from participating in the study. 1. Patients requiring a legally acceptable representative 2. Patients with type 1 diabetes 3. Patients who have received an SGLT2 inhibitor, subcutaneous injection of insulin, or subcutaneous injection of glucagon-like-peptide-1 agonist within 12 weeks before consenting to study participation 4. Patients with the stage-III hypertension (early morning systolic blood pressure measured at home is 175 mmHg or higher, or systolic blood pressure measured at office is 180 mmHg or higher) 5. Patients with chronic respiratory disease that needs medical treatment 6. Patients with pulmonary hypertension 7. Patients with severe renal failure (GFR is below 45 mL/min/1.73 m2) 8. Patients with an infectious disease or undergoing cancer treatment 9. Patients who have undergone surgery or catheter treatment within a year before consenting to study participation 10. Patients who are or may be pregnant 11. Patients who are drug addicted or alcohol dependent 12. Patients with NYHA III-IV heart failure 13. Patients considered inappropriate by their attending investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount and percentage change in right ventricular systolic pressure (PASP) under exercise stress between the baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measurement at each observation point, and the amount and percentage change in right ventricular systolic pressure (PASP) under exercise stress at the observation week 6 Measurement and amount and percentage change from the baseline to each observation point for the following parameters: 2. Left ventricular ejection fraction (EF; %) as contractility 3. Left ventricular diastolic performance [E/A, Dec-time, and tissue Doppler echocardiography (e')] 4. Left atrial pressure (E/e') 5. Right ventricular systolic pressure as right heart function 6. Exercise tolerance measured during cardiopulmonary exercise testing (minute ventilation volume, carbon dioxide excretion, oxygen intake at peak and anaerobic metabolic thresholds) 7. Blood pressure measured at home (early morning blood pressure measured immediately before starting the administration and 2-week mean of blood pressure measured before sleep) 8. CAVI value 9. Body weight, abdominal circumference, and body composition 10. Amount of physical activity 11. Vital signs and general blood/urine tests 12. Special blood/urine tests 13. Incidence of pulmonary hypertension (50 mmHg or higher at rest, or 60 mmHg or higher with load) before and after exercise load (within case comparison between time points during exercise load should be made using data obtained with the same load level) 14. Incidence of hypoglycemia 15. Low blood pressure incidence 16. Incidence of abnormal electrolyte levels (low Na and K) 17. Incidence of other adverse events | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed