Type 2 Diabetes Mellitus
Conditions
Interventions
Luseogliflozin 214 weeks
Sponsors
Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Body mass Index more than 23 More than estimated GFR 30 Written informed consent was obtained from all patients enrolled in the this Study
Exclusion criteria
Exclusion criteria: contraindication of Luseogliflozin, type 1 diabetes mellitus, cancer, history of severe hypoglycemia, ketoacidosis, skin disease during treatment, repeated genital infection and urinary tract infection Sleep disorder related to the otolaryngology disease, neurological disease, hypothyroidism and acromegaly. Severe hepatic insufficiency defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. Total bilirubin >2.0 mg/dL . Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IgG, Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody. History of unstable or rapidly progressing renal disease. Volume depleted patients. Recent Cardiovascular Events in a patient: Acute Coronary Syndrome (ACS) within 2 months prior to enrolment, Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment, Acute Stroke or TIA within two months prior to enrolment, and Less than two months post coronary artery revascularization Pregnant or breastfeeding patients. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Patients using other SGLT2 inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c, fasting glucose level, energy intake, and eating behavior. The association between energy intake and HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight, Abdominal circumference, Lipid profile, liver function test, renal function, heart function, and organ damage marker. The severity of nocturia and sleep time. The frequency of hypoglycemia. The change of intestinal bacterial flora. | — |
Countries
Japan
Contacts
Public ContactShinya Furukawa
Ehime University Graduate School of Medicine Department of Epidemiology and Preventive Medicine
Outcome results
None listed