type 2 diabetes mellitus
Conditions
Interventions
Administer Luseogliflozin 2.5 mg once a day in the morning. When glycemic control is inadequate, the medicine can be increased up to 5 mg.
Sponsors
Minami Osaka Hospital Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes mellitus who had received diet, exercise therapy, and glucose-lowering therapy for at least a month before participation and had a glycated hemoglobin level of at least 7.0% and no more than 10.0% 2) Patients with fasting plasma triglycerides at least 120 mg/dL and no more than 400 mg/dL 3) Patients with an estimated glomerular filtration rate (eGFR) at least 30 mL/min per 1.73m2 4) Patients who are 20 years old or older 5) Patients who have agreed to participate in this study 6)Patient with body mass index (BMI) 20 kg/m2 or more
Exclusion criteria
Exclusion criteria: 1) Patients with type 1 diabetes mellitus 2) Patients who had current change in dose or usage of antidiabetic and dyslipidemia drugs within a month 3) Patients who currently used other SGLT2 inhibitor within a month of screening (Patients who have suspended using SGLT2 inhibitor for more than a month can participate. ) 4) Patients with a history of severe ketosis, diabetic coma, or precoma within six months before participation 5) Patients with proliferative retinopathy 6) Patients with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73m2 at screening, or patients who need renal dialysis 7) Patients with dysuria 8) Patients with urinary tract infections or genital infections 9) Patients who have severe infection, serious injury or who are before of after operation 10) Patients with a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, or severe heart disease (NYHA Class III-IV) within 6 months 11) Patients who are pregnant or breast-feeding or planning to become pregnant 12) Patients with severe liver disfunction (Child-Pugh score: at least 10 and no more than 15) 13) Patients with a history of allergy to Luseogliflozin 14) Patients who are judged to be inappropriate as a subject by an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels, lipid profiles (total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, non HDL cholesterol, apoB, apoA-1, apoB/apoA-1 ratio, RLP cholesterol) 24 weeks after administration | — |
Countries
Japan
Contacts
Public ContactYuriko Hajika
Minami Osaka Hospital Internal Medicine
Outcome results
None listed