Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) HbA1c levels of >=7.0% to <=10.0% (NGSP) 2) BMI >=25 kg/m2 3) Under treatment with fixed diet, exercise ,medication therapy>=4 weeks 4) Age >=20 to <75 years 5) Submission of written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: 1) Under treatment with SGLT2 inhibitor,DPP-4 inhibitor, insulin, or GLP-1 analog 2) Severe ketosis, diabetic coma, or diabetic precoma within the past six months 3) Type 1 diabetes 4) Pituitary gland dysfunction, adrenal gland dysfunction 5) Severe infectious diseases, pre or post surgery, and serious trauma 6) Pregnant women, women suspected of being pregnant, or lactating women 7) Severe renal function disorder (eGFR < 45) 8) Severe liver function disorder 9) History of malignant tumor 10) Cardiac arrest (class of IV in NYHA) 11) Self-contained device such as pacemakers 12) Wearable devices such as Holter electrocardiographs 13) Implantable metallic medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c, and urinary and plasma DPP-4 activities after 12 weeks of treatment with canagliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in glycemic, insulinemic, lipid, and hepatic parameters, body weight, visceral fat area, urinary and plasma DPP-4 activities, and blood pressure and heart rate after treatment with canagliflozin alone or in combination with teneligliptin. | — |
Countries
Japan
Contacts
University of the Ryukyus Hospital Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatolog