Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Changes in HbA1c From Baseline to months 36
研究概览
简要总结
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
详细描述
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
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 with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%
排除标准
- •Type 1 diabetes
- •Gestional 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 the study
- •Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study
研究组 & 干预措施
Triple OADs failure
Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor
干预措施: Empagliflozin 25 MG (Drug)
Triple OADs failure
Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor
干预措施: INS (Drug)
结局指标
主要结局
Changes in HbA1c From Baseline to months 36
时间窗: Baseline, month 36 (3-year)
Changes in HbA1c From Baseline to months 36 (3-year)
次要结局
- Percentage of patients with hypoglycemic episodes(Baseline, month 36)
- Achievement of target HbA1c(Baseline, month 36)
- Changes in HbA1c(Baseline, month 3, 6, 12, 18, 24, 30)
- Changes in lipid profiles(Baseline, month 36)
- Percentage of patients with at least 1 episode of genitourinary tract infections(Baseline, month 36)
- Changes in FPG(Baseline, month 3, 6, 12, 18, 24, 30, 36)
- Changes in body weight(Baseline, month 36)
- Changes in blood pressure(Baseline, month 36)
研究者
Eu Jeong Ku
Clinical Associate Professor
Chungbuk National University Hospital