Type 2 Diabetes Mellitus
Conditions
Interventions
Group A: Administer Dapagliflozin In principle, dapagliflozin is orally taken once a day after breakfast. Patients in the empagliflozin group start with dapagliflozin 5mg per day and in principle
Sponsors
the Japan Society for Patient Reported Outcome (PRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study: 1. Male and female patients who are at age of 20 years or older and younger than 80 years when giving their consent 2. Patients with type 2 diabetes 3. Patients who have not used any antidiabetic medication within 8 weeks before consenting, or those who have only used beguanide 4. Patients with HbA1c 7.1% or higher but no more than 10.0% within 12 weeks before consenting 5. Patients with BMI 23kg/m2 or higher 6. Patients who can give their consent in a written form
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study: 1. Type 1 diabetes mellitus or secondary diabetes 2. Patients with a medical history of diabetic ketoacidosis 3. Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent 4. Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution) 5. Patients with renal disease (serum creatinine 1.3 mg/dL or higher, or eGFR less than 45 mL/min/1.73m2) 6. Patients seemingly with unstable hypertension or dyslipidemia within 12 weeks before consenting 7. Patients with addiction of either alcohol or drugs 8. Patients are currently pregnant, possibly pregnant, breast-feeding, or planning to be pregnant during the study 9. Dehydrated patients (test results show abnormality in hematocrit or BUN, or patients complain to have a symptom of dehydration) 10. Patients with urinary tract infection or genital infection with 12 weeks before consenting 11. Contraindication: patients with hypersensitivity to any medical component of each study drug 12. Contraindication: patients with severe ketoacidosis, diabetic coma or precoma 13. Contraindication: patients during a perioperative period, or with severe infection or physical injury 14. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of achieving a composite endpoint of the following 3 items from baseline to the 24th week 1. HbA1c below 7% 2. Body weight loss of 3% 3. Avoidance of hypoglycemia (Level 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ratio of achieving HbA1c below 7% 2. Ratio of achieving body weight loss of 3% 3. Change in HbA1c 4. Circadian change of blood glucose 5. Day-to-day variability of blood glucose 6. Change in fasting blood glucose 7. Change in body weight and BMI 8. Change in lipid metabolism marker (HDL-chol, T-chol, LDL-chol, TG) 9. Change in eGFR 10. Values from the general blood test (blood cell count, Na, K, Cl, uric acid, serum creatinine, AST, ALT, BUN, IRI, HOMA-R) 11. Ratio of avoiding hypoglycemia (Level 2) [achievement rate] 12. Frequency and onset time of hypoglycemia (Level 1) 13. Frequency and onset time of hypoglycemia (Level 2) 14. Frequency of experiencing hypoglycemia (Level 3) 15. Medication adherence rate | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed