A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000014388
- Lead Sponsor
- Kato clinic of Internal medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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) With moderate or severe renal dysfunction (Serum Creatinin male: >= 1.5 mg/dL, female: >= 1.3 mg/dL) 5) Is receiving SGLT-2 inhibitor, insulin at initiation 6) Is nursing or pregnant or planned to become pregnant 7) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragriflozin 8) 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 and percent change in following items from baseline to 12 weeks 1) AUC of blood glucose 160 mg/dL or less by CGM 2) AUC of urinary glucose by SMUG 3) 2-hour postprandial blood glucose and urinary glucose levels 4) Body composition (body fat, and body water) 5) Glycoalbumin (GA) 6) Body weight 7) Waist circumference 8) Serum lipids 9) Blood pressure 10) Other information such as diet record, include DTR-QO