Type 2 diabetes mellitus
Conditions
Interventions
SGLT-2 inhibitor(+)
Sponsors
Chubu-Rosai Hospital Department of Diabetes and Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The outpatients with type 2 diabetes mellitus who are periodically visiting our hospital. HbA1c(NGSP) level less than 10%,and type 2 diabetes patients who recieve diet and exercise therapy and/or taking oral hypoglycemic agents. 1.BMI >=22kg/m2and35kg/m2=< 2. age >=20 Male and Female
Exclusion criteria
Exclusion criteria: 1.Patient who had myocardial infarction within the past six months. 2.Patient with a severe ketotic diabetic coma or precoma. 3.Patient with severe infectious disease (especially urinary tract infection), before and after operation, and a serious injury. 4.Patient with a past history of hypersensitivity for Ipragliflozin. 5.A pregnant woman or woman who may be pregnant. 6.Elderly person (>70 years). 7 Patient with hypoalimentation or dehydration. 8.Patient who is considered to be inappropriate by the chief physician. During the entire study period, when the chief physician judges that the continuing participation in this study became difficult, by aggravation such as HbA1c or blood glucose level and other factors, the appropriate treatment should be done immediately: administration of other antihyperglycemic agent or other appropriate measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)glucose metabolism: at the baseline and the end of the study. 1)HbA1c,1,5-AG 2)Fasting plasma glucose, insulin, HOMA-R 3)Blood ketone body, free fatty acid, Adiponectin (2)The change of body weight/Body Mass Index(BMI)/body fat ratio: measuring every day through study period. (3)Continuous Glucose Monitoring (CGM system-Gold TM): at the baseline and the end of the study period, we measure the blood glucose profile for 72 hours before and after Ipragliflozin treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)24 hours urine glucose amount and electrolyte (include Na, Ca) excretion in urine:measuring at the baseline and during trial period, we measure the amount of urine sugar/24 hours and quantity of urine electrolyte under hospitalization. (2)Lipid metabolism: serum T-chol, HDL-C, LDL-C, TG, RLP-chol, LP(a), small dense LDL, MDA-LDL: measuring at the baseline and the end of the study period. (3)Liver function, renal function, hematocrit level, amino acid analysis, lactic acid, pyruvic acid, BNP etc, measuring at the baseline and the end of the study period. (4)The markers of tubular impairment (such as urinary beta2-MG, urinary NAG, urinary type IV collagen, L-FABP): measuring at the baseline and the end of the study period. | — |
Countries
Japan
Contacts
Public ContactMinoru Kusama
Chubu-Rosai Hospital Department of Diabetes and Endocrinology
Outcome results
None listed