Type 2 Diabetes mellitus
Conditions
Interventions
Orally administration of 20 mg tofogliflozin once a day for 8 weeks, and 8 weeks discontinuation
Sponsors
Kanazawa Medical University
Kakuda Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The male patients with type II diabetes mellitus. 1) Age range from 20 to 74 2) Glycated hemoglobin less than 9.0 %
Exclusion criteria
Exclusion criteria: 1) Patient who had SGLT2 inhibitor with past 2 months. 2) Patient whose concomitant drug had changed with past 2 months. 3) Patient who is diagnosed as contraindication of tofogliflozin. (1) Patient with a history of hypersensitivity to any of the components of the product (2) Patient with a severe ketotic diabetic coma or precoma. (3) Patient with severe infectious disease, before and after operation, and a serious injury. 4) Patient receiving other diabetes drugs. 5) Patient with severe renal disorder (estimated GFR< 30mL/min/1.73m2). 6) Patient with a history of cerebral infarction. 7) Patient receiving diuretic drugs. 8) Patient whom the principle investigator or other investigator consider unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in postprandial area under curve of serum triglycerides from baseline to 8week drug treatment to 8week discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the following items from baseline to 8week drug treatment to 8week discontinuation. 1) plasma sample Glucose metabolism, lipid metabolism, electrolyte, hepatic function, atherosclerotic index. 2) urine sample Glucose metabolism, electrolyte, renal function 3) Physical examination Blood pressure, body weight, waist circumference, body mass index, PWV | — |
Countries
Japan
Contacts
Public ContactJunji Kobayashi
Kanazawa Medical University Department of General Internal Medicine
Outcome results
None listed