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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2; D003924

• Registration Number: JPRN-jRCTs051180165
• Lead Sponsor: Ishii Hitoshi

Brief Summary

This study enrolled patients with mild type 2 diabetes mellitus. Dapagliflozin improved the QOL of the subjects. The body weight reduction by dapagliflozin seemed to contribute to the QOL improvement. Dapagliflozin also improved HbA1c, HDL-c, and urinary albumin. No safety concern was observed in both groups. These results suggested that dapagliflozin can be used as the first-line drug to the mild diabetes patients. New findings in this study may improve treatment and education to the diabetes patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2020-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 253

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with improved in Overall quality of life domain of SHIELD-WQ-9 at week 24

Secondary Outcome Measures

Name	Time	Method
The following evaluation items from baseline to week 24<br>1.Proportion of patients with improved in each domain of SHIELD-WQ-9 (except for the primary endpoint) <br>2.Changes in the DTR-QOL domain scores<br>3.Change in EQ-5D-5L<br>4.Medication preference<br>5.Relationships between medication preference and each questionnaire<br>6.Body weight, BMI, abdominal circumstance<br>7.Correlation between QOL scores and blood tests or urine tests<br>8.Occurrence of adverse event (ratio of hypoglycemia, etc.)<br>9.Medication adherence<br>10.Adherence to dietary therapy