JPRN-jRCTs051180165已完成未知
The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL - J-BOND Study
Ishii Hitoshi0 个研究点目标入组 253 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 253
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes MellitusType 2 Diabetes mellitusJPRN-UMIN000019192Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University60
已完成
不适用
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in TaiwanType II Diabetes MellitusNCT03084965AstraZeneca1,987
已完成
4 期
Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)Type 2 DiabetesNCT04004793Shanghai Zhongshan Hospital328
已完成
4 期
A randomized controlled trial of Ipragliflozin and sitagliptiType 2 diabetesJPRN-jRCTs031180205Sone Hirohito115
已完成
3 期
Double-Blind Study of Miglitol in Japanese With type2 DiabetesType 2 Diabetes MellitusNCT00380822Sanwa Kagaku Kenkyusho Co., Ltd.