Type 2 diabetes mellitus
Conditions
Interventions
take Tofogliflozin orally One day and 8 weeks
Sponsors
University of Juntendo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -type 2 diabetes mellitus men -BMI range: 18.5-30 kg/m2 -HbA1c range:7.5-10.0% -The patient who did not being changed the way to take diabetes medicines(additional dosage, discontinulation of administration or changing dosage) within 12 weeks before agreement acquisition -Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding
Exclusion criteria
Exclusion criteria: -type 1 diabetes mellitus -past history of taking Tofogliflozin -BMI range:>30 or <18.5 kg/m2 -liver dysfunction(AST,ALT => 51U/L,gamma-GTP over 101U/L) -renal dysfunction or eGFR level =< 60mL/min/1.73m2 -Patient with severe heart diseases (for example, heart failure and unstable angina) or the patient who occured myocardial infarction and anginal attack after 24 weeks ago from observation period -patient who had an apoplexy spasm (cerebral infarction and cerebral hemorrhage) within 24 weeks until agreement acquisition -patient with malignant tumor -patient with advanced diabetes complications (neuropathy , retinopathy and nephropathy) -patient of serious illness ketotic, a diabetic coma or the previous coma -Patient with the endocrine diseases for which treatment is insufficient for hormone replenishment method of treatment (for example,pituitary disease, thyroid disease and adrenal disease) -anemia beyond the degree of middle class (hemoglobin < 9.5g/dL) -drunkard(for example 1 daily mean sake, by 3 gou and beer, more than 3 flagons) -subjects judged unsuitable to the study from staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, a single effect and chronic effect. | — |
Secondary
| Measure | Time frame |
|---|---|
| After administration of Tofogliflozin -Intrahepatic lipid -Intramyocellular lipid -Visceral fat area -Subcutaneous fat area -Body weight, Body composition -Endogenous glucose production -Insulin sensitivity -Metabolic flexibility -Metabolome analysis | — |
Countries
Japan
Contacts
Public ContactHideyoshi Kaga
University of Juntendo Department of Endocrinology and Metabolism, Sportology Center
Outcome results
None listed