Type2 Diabetes
Conditions
Interventions
Luseogliflozin Dosing period : 12 weeks Dose : 2.5mg/day(1 tablet per 1 day)
Sponsors
Medical Corporation H.E.C Science Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Document consent has been obtained for participation in this study Type 2 Diabetes Age >20 HbA1c 6.5-10.5 % BMI >22 kg/m2 Hypertension that meets one of the following criteria SBP >130mmHg Using antihypertensive agents (including diuretics) Not taking the diabetes medicine or the oral hypoglycemic medicine from 1 to 3 who are to continue taking the same drug and the same dose (SGLT2 inhibitors except) Continued a certain diet
Exclusion criteria
Exclusion criteria: The patients who had another type of type 2 diabetes Secondary hypertension SBP > 180mmHg or DBP >110mmHg Have a medical history of cardiovascular events Have a severe kidney disease or a severe liver disease Have a the malignant tumor, or those who have a medical history of malignant tumor Taking SGLT2 inhibitor within 12 weeks before the start of administration Patients with contraindication of Luseogliflozin Considered as inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c 24-hour blood pressure (24-hour average blood pressure, daytime average blood pressure, night time average blood pressure) Outpatient blood pressure (systolic blood pressure, diastolic blood pressure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose Fasting insulin Fasting C-peptide Fasting glucagon HOMA-IR HOMA-beta iHOMA2 Plasma renin activity Aldosterone concentration Adrenaline Noradrenaline Dopamine Angiotensin 2 TG TC LDL-C HDL-C non-HDL-C Free fatty acid Adiponectin Uric acid Body weight Waist Amount of body fat mass Amount of Lean fat mass Intracellular water content Extracellular water content Body water content Protein mass Muscle mass Mineral content NO High sensitivity CRP Urinary protein (quantitative) Urinary creatinine Urinary sugar Urine sodium Urinary chlorine Urinary albmin Mean arterial pressure Pulse pressure Double product SD and CV of blood pressure in each period of 24-hour, daytime, nighttime Target value achievement rate of 24 hours, daytime nighttime blood pressure values after administration 12 weeks Improvement rate of nighttime hypertension Systolic blood pressure and diastolic blood pressure in Non-dipper type patient and Dipper-type patients Improvement rate of early morning hypertension Systolic blood pressure and diastolic blood pressure in early morning hypertension patients Improvement rate of morning surge Ambulatory arterial stiffness index Hyperbaric area Trough/Peak Smoothness Index | — |
Countries
Japan
Contacts
Public ContactTakashi Makuuchi
Medical Corporation H.E.C Science Clinic Clinical Trial Secretariat
Outcome results
None listed