type 2 diabetes mellitus
Conditions
Interventions
Sodium-dependent glucose co-transporter 2 inhibitors(SGLT2 inhibitors)
Sponsors
Ise Red Cross Hospital Department of Metabolic Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients 2) Inadequate glucose control even after dietary, exercise and drug therapies for more than 8 weeks 3) HbA1c 6.5 - 10.0% 4) Fasting blood glucose levels 110 - 250mg/dl 5) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) Had ketosis or coma within 6 month 3) Secondary diabetes 4) Patients receiving GLP-1 analogue therapy 5) Poor-controlled diabetes (HbA1c>=10.0 % or fasting blood glucose levels>=250mg/dl) 6) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 7) Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis 8) Renal insufficiency: Ccr<45 mL/min/1.73m2 9) Patients who have serious complication of gastrointestinal disorders or who underwent a surgical operation that is known to affect the absorption of a drug by digestive tract 10) Patients who are susceptible to dehydration 11) Patients who is a chronic heavy drinker 12) Patients with history of urinary infection or genital infection disease 13) Malignancies or other diseases with poor prognosis 14) Pregnant 15) Subjects whose doctor in charge do not agree to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| grip strength, quadriceps muscle strength | — |
Secondary
| Measure | Time frame |
|---|---|
| abdominal fat free area and visceral fat area, Hemoglobin A1C levels, pre/postprandial blood glucose levels, BMI | — |
Countries
Japan
Contacts
Public ContactSatoshi Ida
Ise Red Cross Hospital Department of Metabolic Diseases
Outcome results
None listed