Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000014790
- Lead Sponsor
- Japan Community Health care Organization Kanazawa Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
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 severe hepatic dysfunction (Over grade 3 in classification criteria for severity of adverse drug reactions) 5) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 6) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 7) Is receiving SGLT-2 inhibitors, GLP-1 antagonists, or insulin therapy at consent 8) Is nursing or pregnant or planned to become pregnant 9) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 10) 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 24 weeks
- Secondary Outcome Measures
Name Time Method Change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for 24 week), GA 2) Body weight 3) Fasting plasma glucose 4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide 5) Waist circumference (Except for 12 week) 6) Blood pressure and heart rate 7) Uric acid 8) Serum cystatin C (Except for 12 week) 9) Serum lipids (TC, LDL-C, HDL-C, and TG) 10) RLP-C (Remnant like particles cholesterol) (Except for 12 week) 11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week) 12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)