Type 2 diabetes
Conditions
Interventions
Sponsors
Imamura clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20 to 80 years at providing consent 2) Poorly glycemic controlled patients nevertheless who undergoes insulin and DPP-4 inhibitors combination therapy at least 12 weeks, or patients with DPP-4 inhibitor is interrupted and insulin solely treatment because of poorly glycemic control 3) HbA1c >= 7.0 and < 9.5% 4) BMI >= 22 kg/m2 5) Received informed consent
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) Moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 5) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 6) Is receiving SGLT-2 inhibitor at initiation 7) Is nursing or pregnant or planned to become pregnant 8) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 9) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change and percent change in HbA1c from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change and percent change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for the change at 24 week) 2) Fasting plasma glucose,CPR, CPI 3) Body weight and waist circumference 4) Serum lipid (TC, LDL-C, TG, HLD-C) 5) Sitting blood pressure 6) Adiponectin, hs-CRP, TNF-alpha | — |
Countries
Japan
Contacts
Public ContactKenichi Imamura
Imamura clinic Medical director
Outcome results
None listed