Investigation of the efficacy and safety of ipragliflozin in obese patients with type 2 diabetes undergoing metformin (Met)
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000014638
- Lead Sponsor
- Association of medical corporation Toyukai, Yutenji Medical Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method 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)