STRIDE Study to evaluate the effect of Tofogliflozin on VRH In T2DM using ECG
Not Applicable
Recruiting
- Conditions
- Type2 diabetes mellitus with obesity and high blood pressure
- Registration Number
- JPRN-UMIN000043061
- Lead Sponsor
- Sapporo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of hypersensitivity to tofogliflozin 2) Severe ketosis, diabetic coma or precoma 3) Ssevere infections, before and after surgery, and with serious trauma 4) Taking tofogliflozin in the past 5) Atrial fibrillation 6) With artificial pacemaker, or implantable cardioverter-defibrillator 7) Chronic kidney disease (CKD) stage 4 and 5 8) Pregnancy, lactating women, patients with the intention of becoming pregnant 9) Patients judged inappropriate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of QTcd from baseline
- Secondary Outcome Measures
Name Time Method 1) Changes of QTcd and TpTe from baseline at 24 and 52 weeks of administration 2) Evaluation of the relationship between QTcd / TpTe and various factors at 24 and 52 weeks of administration 3) Changes from baseline in various factors at 8, 24, and 52 weeks of administration 4) Adverse events