Type2 diabetes mellitus with obesity and high blood pressure
Conditions
Interventions
None listed
Sponsors
Sapporo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes mellitus 2) Administered tofogliflozin within 8 weeks 3) Blood Pressure >= 130/80 mmHg 4) BMI >= 25 kg/m2 5) Patients undergoing electrocardiography within 12 weeks 6) 20 years or older and under 80 years
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of QTcd from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTatsuya Sato
Sapporo Medical University School of Medicine Department of Cellular Physiology and Signal Transduction / Department of Cardiovascular, Renal and
Outcome results
None listed