Effect of concomitant use of formula diet with dapagliflozin on body compositions, metabolic improvement, and its safety in type 2 diabetes mellitus.
Not Applicable
- Registration Number
- JPRN-UMIN000024580
- Lead Sponsor
- onprofit Organization Hokkaido Health-Science Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Not provided
Exclusion Criteria
1) Type 1 diabetic patients 2) Patients who use SGTL2 inhibitor in the past 3) Patients with hypersensitivity to the ingredient(s) of said drug 4) Patients suffering from severe ketosis, diabetic coma, or precoma 5) Patients treated with insulin 6) Patients who are judged to be inadequate to participate in this study by a doctor in charge 7) Patients with eGFR <45 ml/min/1.73 m2 8) Patients having a plan of pregnancy 9) Pregnant women, patients who might be pregnant, and lactating women 10) Patients with severe infections, patients before or after operations or having serious external injuries 11) Patients with allergy to said food ingredients (soy bean, egg, yeast,milk)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The variation of HbA1c from starting time of the therapy to 24 weeks after starting the therapy in between two groups Summary statistics of the change of HbA1c is calculated, and the variation from starting time of the therapy to 24 weeks after starting the therapy are compared between the two groups by the two sample t-test.
- Secondary Outcome Measures
Name Time Method