JPRN-jRCTs051180018已完成4 期
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. - SUMS-ADDIT-2
Morino Katsutaro0 个研究点目标入组 52 人开始时间: 2018年12月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
Twenty-four weeks of dapagliflozin add-on treatment effectively reduces body mass, mainly by reducing fat mass, in inadequately controlled patients with type 2 diabetes who are treated with oral anti-diabetic agents. Whole-body muscle mass is maintained, but IHTG content is reduced by dapagliflozin treatment. Although there was a small difference in the change of plasma serine concentrations between the two groups in this study, most amino acids showed subtle changes after treatment of dapagliflozin for 24
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
- •Ambulatory type 2 diabetes mellitus patients on oral therapy who are obese and have not achieved target blood glucose levels.
- •Patients who satisfy all of the following criteria:
- •1)Over 20 and less than 75 years of age at the time of informed consent acquisition
- •2)Type 2 diabetes mellitus patient on oral therapy
- •3)Patients whose HbA1c is more than 7.0% and less than 10.0%
- •4)Patients whose BMI is more than 23 kg/m2
- •5)Patients whose eGFR more than 45 ml/min/1.73 m2
- •6)Patients who are ambulatory
- •7)Patients who received explanation of the research using an informed consent form and gave written consent on research participation
排除标准
- •1)Patients who have taken SGLT2 inhibitors
- •2)Patients treated with insulin, GLP-1 receptor agonists
- •3)Patients with severe ketosis, diabetic coma or precoma
- •4)Patients corresponding to the contraindication of dapagliflozin (hypersensitivity, pregnant women etc.)
- •5)Patients with a history of hospitalization within six months for trauma, surgery and infectious diseases
- •6)Patients with past history of cerebral infarction, transient ischemic attack
- •7)Patients with past history of unstable angina, myocardial infarction within six months
- •8)Patients treated with loop diuretics
- •9)Patients with orthostatic hypotension
- •10)Patients deemed inappropriate to participate in the research by the investigator
研究者
相似试验
已完成
不适用
Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. SUMS-ADDIT-2Type 2 diabetesJPRN-UMIN000020239Shiga University of Medical Science52
已完成
不适用
Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin TherapyType 2 diabetesJPRN-UMIN000018839Shiga University of Medical Science50
已完成
4 期
Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.OverweightCarbohydrateSodium-glucose Transporter 2 InhibitorsNCT06383832Sun Jia36
已完成
4 期
Foxiga Korea Local Phase 4 StudyDiabetes Mellitus, Type 2NCT02564926AstraZeneca125
已完成
2 期
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin SecretionMetabolic Syndrome XNCT02113241University of Guadalajara24