Type 2 diabetes
Conditions
Interventions
Sponsors
Association of medical corporation Toyukai, Yutenji Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20 to 75 years at providing consent 2) Poorly glycemic controlled patients with HbA1c over 7.0% at least 2 points within 12 weeks before initiation, nevertheless who undergoes metformin treatment over 12 weeks 3) HbA1c >= 7.0% 4) BMI >= 25 kg/m2 5) Received informed consent
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 3) With severe ketosis, diabetic coma, or precoma 4) With severe infection, pre or post surgery, and serious trauma 5) Has history of lactic acidosis 6) With severe hepatic disorder 7) With gastrointestinal disorder such as diarrhea or vomiting, concerning dehydration or dehydration status 8) Moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL) 9) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months 10) Is receiving SGLT-2 inhibitor, insulin therapy at initiation 11) Is pregnant, nursing, or planned to become pregnant 12) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change or percent change in following items from baseline to 12 weeks 1) Body weight 2) Waist circumference 3) Serum lipids 4) Blood pressure 5) Fasting plasma glucose 6) Adiponectin 7) Measurement of body composition using body composition analyzer (MC-780A, Manufactured by TANITA) | — |
Countries
Japan
Contacts
Public ContactKotaro Shimokawa
Association of medical corporation Toyukai, Yutenji Medical Clinic Medical director
Outcome results
None listed