The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL

JRCT ID: jRCTs051180165

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 30/03/2018
• Target sample size: 252
• Study type: Interventional

Intervention(s)

Group A: Administer dapagliflozin
Group B: Administer DPP-4 inhibitor

Outcome(s)

• Primary Outcome: Proportion of patients with "improved" in "Overall quality of life" domain of SHIELD-WQ-9 at week 24

Secondary Outcome

The following evaluation items from baseline to week 24
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.Body weight, BMI, abdominal circumstance
7.Correlation between QOL scores and blood tests or urine tests
8.Occurrence of adverse event (ratio of hypoglycemia, etc.)
9.Medication adherence
10.Adherence to dietary therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ishii Hitoshi
• Source(s) of Monetary Support: AstraZeneca K.K.,AstraZeneca K.K.
• Secondary ID(s): UMIN000030514