type 2 diabetes mellitus
Conditions
Interventions
Group A: Administer dapagliflozin
Group B: Administer DPP-4 inhibitor
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. T2DM patients who are newly started treatment with an OHA 2. Patients with HbA1c 6.5% or higher at consenting 3. Patients with BMI 23 kg/m2 or greater 4. Male and female patients aged 20 years or older and younger than 75 years when giving their consent 5. 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. Patients with any experience of using any antidiabetic medication within last three months 2. Patients with medical history of severe hypoglycemia within a year 3. Patients with type 1 diabetes mellitus or secondary diabetes 4. Patients during a perioperative period, or patients with severe infection or severe physical injury 5. Patients with moderate to severe heart failure (NYHA/New York Heart Association at class III or higher) 6. Patients with moderate renal disease (eGFR < 45mL/min/1.73 m2) 7. Patients with severe liver disease (AST 100 IU/l or higher) 8. Patients who are addicted to alcohol or a drug 9. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant 10. Patients with dementia 11. Patients with a contraindicated condition to use the study drug 12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with "improved" in "Overall quality of life" domain of SHIELD-WQ-9 at the 24th week | — |
Secondary
| Measure | Time frame |
|---|---|
| The following evaluation items from baseline to the 24th week 1. Proportion of patients with "improved" in each domain of SHIELD-WQ-9 (except for the primary endpoint) 2. Changes in the DTR-QOL domain scores 3. Change in EQ-5D-5L 4. Medication preference 5. Relationships between medication preference and each questionnaire 6. HbA1c 7. Body weight, BMI, abdominal circumstance 8. lipid metabolism marker (TC, HDL-C, TG, LDL-C) 9. Renal function marker (eGFR, urinary albumin) 10. Correlation between QOL scores and blood test results as well as urine test results 11. Occurrence of adverse event (ratio of hypoglycemia, etc.) 12. Medication adherence rates 13. Adherence rates to dietary therapy | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed