NCT03473262已完成不适用
Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Changes in HbA1c From Baseline to Week 24
研究概览
简要总结
This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy 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
- •Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c >7.5% and <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
结局指标
主要结局
Changes in HbA1c From Baseline to Week 24
时间窗: Baseline, Week 24
Changes in Fasting Plasma Glucose From Baseline to Week 24
时间窗: Baseline, Week 24
次要结局
- Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24(Baseline, Week 24)
- Changes in HbA1c From Baseline to Week 12(Baseline, Week 12)
- Changes in Fasting Plasma Glucose From Baseline to Week 12(Baseline, Week 24)
- Changes in Weight Between Baseline and Week 24(Baseline, Week 24)
- Changes in Body Mass Index Between Baseline and Week 24(Baseline, Week 24)
- Changes in Total Cholesterol Between Baseline and Week 24(Baseline, Week 24)
- Changes in HDL Cholesterol Between Baseline and Week 24(Baseline, Week 24)
- Changes in LDL Cholesterol Between Baseline and Week 24(Baseline, Week 24)
- Changes in Triglycerides Between Baseline and Week 24(Baseline, Week 24)
- Changes in Systolic Blood Pressure Between Baseline and Week 24(Baseline, Week 24)
- Changes in Dystolic Blood Pressure Between Baseline and Week 24(Baseline, Week 24)
- Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24(Baseline, Week 24)
- Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24(Baseline, Week 24)
研究者
Eu Jeong Ku
ChungbukNUH
Chungbuk National University Hospital
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