Patients with Type 2 diabetes
Conditions
Interventions
Luseogliflozin (2.5 mg/dose) will be orally administered once a day before or after breakfast for 24 weeks If responses are insufficient, the dose may be increased to 5 mg (once a day) after testi
Sponsors
Medical corporation Jinnouchi society Jinnouchi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with HbA1c (NGSP level) between 7.0% and 10.5% at the time informed consent is obtained (2) Patients previously treated with dietary therapy for more than 4 weeks prior to the start of treatment with luseogliflozin (3) Patients who have not been previously treated with any antidiabetics within 4 weeks prior to the start of treatment with luseogliflozin (4) Patient between 20 years and 65 years old, regardless of sex, at the time informed consent is obtained (5) Outpatients (6) Patients who understand the explanation provided regarding the clinical study and can provide written informed consent
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with diabetes other than Type 2 diabetes, including Type 1 diabetes, diabetes associated with diseases other than Type 2 diabetes and gestational diabetes (2) Patients with severe renal function impairment, including nephrotic syndrome, renal failure and dialysis (3) Patients with severe hepatic function impairment, including cirrhosis (4) Patients with severe heart diseases, including heart failure, myocardial infarction and cerebral infarction, or patients with prior history of any of these diseases during the past 6 months (5) Patients with severe diabetic microvascular diseases, including diabetic retinopathy and diabetic neuropathy that does not sufficiently respond to treatment (6) Patients with concurrent or prior history of malignant tumors, excluding those not receiving treatment for their disease and who have not experienced recurrence and those who are not likely to experience recurrence during participation in the study (7) Patients who have previously developed hypersensitivity to luseogliflozin (8) Patients who are alcoholics (9) Females who are pregnant or are likely to be pregnant, or those who want to become pregnant during participation in the study and nursing mothers (10) Patients who the physician in charge determines as ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary glucose level, CGM, HbA1c, fasting blood glucose level and body weight from before the start of treatment until completion (Week 24) or discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine volume at measurement of urinary glucose, subcutaneous fat, visceral fat, insulin, EPA/AA ratio, FFA, ghrelin, blood ketone bodies, 1.5-anhydro-D-glucitol, and QOL from before the start of treatment until completion (Week 24) or discontinuation of treatment | — |
Countries
Japan
Contacts
Public ContactThe study secretariat
Satt Co.,Ltd Clinical study promotion group
Outcome results
None listed