Type2 diabetes mellitus
Conditions
Interventions
Canagliflozin 100mg, administration of once a day, for 6 days
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital, Clinical Pharmacology Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 25 years and < 75 years 2. Male and Female 3. Patients whose symptoms of type2 diabetes are stable. 4. If patients treated with one or two oral hypoglycemic agents, dose of them are stable over 3months. 5. BMI >=20kg/m2 and <=35kg/m2 6. HbA1c >= 7.0% and <= 10.0% 7. SBP >= 95mmHg and<= 160 mmHg, DBP >= 50 mmHg and <=100mmHg 8. Estimated glomerular filtration rate (eGFR)>=60 ml/min/1.73m2 9. Consent to study participation has been obtained in writing from the patient personally
Exclusion criteria
Exclusion criteria: 1. Patients who have not received treatment of type 2 diabetes mellitus(diet therapy, exercise therapy, oral hypoglycemic agent and so on) 2. Patient with type 1 diabetes mellitus or with history of secondary diabetes mellitus 3. Patients who have experienced repeated severe hypoglycemic episodes 4. Patients with the history of serious diabetic complications requiring treatment 5. Patients treated with insulin, GLP-1 receptor agonist, SGLT-2 inhibitor, diuretic (including drug combination) 6. Patients with history of , or concurrent complication that affect renal function(renal disease, renal stone, prostatic inflammation and so on) , or patients with urinary-tract infection 7. Patients with history of drug or food allergies 8. Patients with history of myocardial infarction, congestive heart failure, unstable angina, cerebrovascular disease(except for lacunar infarction)within 6 months prior to screening visit (confirmation of eligibility) 9. Patients with history of TIA or cerebral infarction with clear neurological symptoms 10. Patients with peripheral arterial disease; Fontaine grade 3 or 4 11. Patients who correspond to contraindication or careful administration of canagliflozin (except for patient under treatment of hypoglycemic agents) 12. Patients with history of atrial fibrillation 13. Patients who are judged as inappropriate by investigators on screening examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary volume, the change of urinary volume, correlation between those parameters and factors which are related to urinary volume change | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose, the change of GLP-1 concentration, safety(adverse event, general clinical examination, electrocardiogram) | — |
Countries
Japan
Contacts
Public ContactTetsuya Tsuji
Quintiles Transnational Japan K.K. Medical Affairs & Clinical Science
Outcome results
None listed