Head-to-head Comparison of Quadruple Combination Therapy With Empagliflozin and Dapagliflozin in Patients With Poorly Controlled Type 2 Diabetes (T2D) Despite Three Existing Oral Antidiabetic Drugs (OAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Changes in HbA1c from baseline to week 156 (3-year)
研究概览
简要总结
This open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple OAD combination.
详细描述
All participants included in this study were initially requested to initiate therapy with insulin, but they insisted on another form of OAD. When participants declined insulin injection and requested another OAD, they were not randomly assigned to each groups. It is fairly common among participants with T2D to decline insulin therapy, despite being aware of its importance and the benefits in controlling blood glucose. Their lack of willingness to use insulin is explained by their avoidance of painful injections, the potential for body weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be effective and safe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12%
排除标准
- •Type 1 diabetes
- •Gestational diabetes
- •Diabetes due to secondary causes
- •Receiving anticancer treatment
- •Receiving glucocorticoids or immune-suppressants
- •have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study
研究组 & 干预措施
Triple OADs failure
Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors.
干预措施: Empagliflozin (Drug)
Triple OADs failure
Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors.
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Changes in HbA1c from baseline to week 156 (3-year)
时间窗: Baseline, week 156 (3-year)
Changes in HbA1c from baseline to week 156 (3-year)
Changes in fasting plasma glucose from baseline to week 156 (3-year)
时间窗: Baseline, week 156 (3-year)
Changes in fasting plasma glucose from baseline to week 156 (3-year)
次要结局
- Changes in systolic blood pressure between baseline and week 104 (2-year)(Baseline, Week 104 (2-year))
- Changes in systolic blood pressure between baseline and week 52(Baseline, Week 52)
- Changes in HbA1c from baseline to week 104 (2-year)(Baseline, week 104 (2-year))
- Changes in total cholesterol between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in HbA1c from baseline to week 52 (1-year)(Baseline, week 52 (1-year))
- Changes in fasting plasma glucose from baseline to week 24(Baseline, Week 24)
- Changes in weight between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in weight between baseline and week 12(Baseline, Week 12)
- Changes in diastolic blood pressure between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in diastolic blood pressure between baseline and week 52(Baseline, Week 52)
- Changes in triglyceride between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in HDL-cholesterol between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in weight between baseline and week 104 (2-year)(Baseline, Week 104 (2-year))
- Changes in weight between baseline and week 52(Baseline, Week 52)
- Changes in weight between baseline and week 24(Baseline, Week 24)
- Changes in systolic blood pressure between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in diastolic blood pressure between baseline and week 12(Baseline, Week 12)
- Changes in fasting plasma glucose from baseline to week 12(Baseline, Week 12)
- Changes in fasting plasma glucose from baseline to week 56 (1-year)(Baseline, Week 56 (1-year))
- Changes in diastolic blood pressure between baseline and week 24(Baseline, Week 24)
- Changes in HbA1c from baseline to week 24(Baseline, Week 24)
- Changes in systolic blood pressure between baseline and week 24(Baseline, Week 24)
- Changes in diastolic blood pressure between baseline and week 104 (2-year)(Baseline, Week 104 (2-year))
- Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in LDL-cholesterol between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)(Baseline, Week 156 (3-year))
- Changes in systolic blood pressure between baseline and week 12(Baseline, Week 12)
研究者
Eu Jeong Ku
Clinical assistant professor
Chungbuk National University Hospital