Study of impact on body weight change and dehydration in the initial administration of Tofogliflozi
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000017062
- Lead Sponsor
- General incorporated Tokyo Physicians Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with a prior history of hypersensitivity to any of the ingredients of tofogliflozin (2) Patients with severe ketosis, diabetic coma, or precoma (3) Patients with severe infections or severe injuries or those who are scheduled to receive or have received surgical treatment (4) Patients with severe hepatic function impairment (5) Patients with end-term renal failure who are on hemodialysis or peritoneal dialysis (6) Patients who are determined by principal investigators or sub-investigators to be ineligible for the clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship between changes in body weight at Week 2 of treatment and the frequency of deviations from upper limit reference values for hematocrit at Week 24
- Secondary Outcome Measures
Name Time Method (1) Safety: frequency of adverse effects and adverse events (events, severity, incidence rates, etc.) (2) Efficacy: changes over time in the parameters listed below. HbA1c (NGSP value), blood sugar, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglycerides, BUN, serum creatinine, uric acid, body weight, blood pressure, hematocrit. (3) Others changes from baseline in HbA1c, body weight, hematocrit, lipid, uric acid, and frequency of adverse events, etc. in tofogliflozin-treated patients after stratification based on baseline values