Type 2 diabetes mellitus
Conditions
Interventions
Canagliflozin (100 mg/day) and glimepiride (0-4mg/day, adjusted by the prescribed algorithm), for 24 weeks
Glimepiride (0-4mg/day, adjusted by the prescribed algorithm), for 24 weeks
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetic outpatients giving written informed consent for the study participation 2) Aged 20-75 years at informed consent 3) Not achieving the individual glycemic target, according to Treatment Guide for Diabetes 2016-2017, by Japan Diabetes Society 4) Undergoing unchanged diet and exercise therapy over 12 weeks 5) Treated with a constant dose of teneligliptin, glimepiride and metformin over 12 weeks (or treated with a constant dose of teneligliptin and glimepiride over 12 weeks, with reasonable reason for not taking metformin) 6) Not taking prohibited concomitant medications over 12 weeks
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes mellitus (2) Need insulin treatment (3) History of hypersensitivity to canagliflozin (4) Heart failure (NYHA class IV) (5) eGFR<45 mL/min/1.73 m2 (6) Severe hepatic dysfunction (7) Pregnancy, nursing or planning to become pregnant during the study (8) Suspected or diagnosed malignant tumors (9) Participating in another interventional study (10) Considered by a study physician to be inappropriate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disposition index, calculated using blood glucose and insulin values, from baseline to at 1-week after the end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in (1) DI-related outcomes (2) DI using C-peptide (3) HbA1c, fasting glucose, fasting insulin (4) Body weight (5) CGM glucose levels (6) HOMA2-% B, iHOMA2 (-% B, -%S) (7) HOMA2-%S (8) Dose of glimepiride | — |
Countries
Japan
Contacts
Public ContactTatsuya Ota
EP-CRSU Co., Ltd. Clinical Research Management Department 1
Outcome results
None listed