Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozi
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000014195
- Lead Sponsor
- Association of medical corporation Ouitsu-kai, Kanno-naika
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) With severe ketosis, history of diabetic or precoma, severe infection, pre or post surgery, and severe trauma, hypersensitivity to ipragliflozin or any other excipient of ipragriflozin 2) With hypophyseal dysfunction or adrenal insufficiency who have high possibility of induces hypoglycemia 3) With urinary tract or genital infection 4) With severe hepatic dysfunction 5) Is receiving SGLT-2 inhibitors at initiation of this study 6) Is nursing or pregnant or planned to become pregnant 7) 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 1) Change and percent change in following items from baseline to 4 week, 12 week, and 24 week fasting plasma glucose HbA1c (Except for the change at 24 week) Body weight 2) Stratification analysis on efficacy of ipragliflozin Dietary composition with BDHQ (intake of carbohydrate and lipid) 3) Palatability change of diet (appetite, incentive to sugar, degree of acquisition desire) Comparison of ipragliflozin treated group with other medicated group