A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 114
- 主要终点
- Change From Baseline of HbA1c After 24 Weeks of Treatment.
研究概览
简要总结
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Empagliflozin 10 mg dose
Empagliflozin open label treatment period
干预措施: BI 10773 (Drug)
Placebo add on 10 mg dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
干预措施: BI 10773 / BI 1356 Placebo (Drug)
Placebo add on 10 mg dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
干预措施: BI 10773 (Drug)
Empagliflozin/Linagliptin 25/5 mg Dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
干预措施: BI 10773 / BI 1356 (Drug)
Empagliflozin/Linagliptin 25/5 mg Dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
干预措施: BI 10773 Placebo (Drug)
Empagliflozin/Linagliptin 10/5 mg Dose.
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
干预措施: BI 10773 / BI 1356 Placebo (Drug)
Empagliflozin/Linagliptin 10/5 mg Dose.
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
干预措施: BI 10773 (Drug)
Empagliflozin/Linagliptin 10/5 mg Dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
干预措施: BI 10773 Placebo (Drug)
Empagliflozin/Linagliptin 10/5 mg Dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
干预措施: BI 10773 / BI 1356 (Drug)
Empagliflozin 25 mg dose
Empagliflozin open label treatment period
干预措施: BI 10773 (Drug)
Empagliflozin/Linagliptin 25/5 mg Dose.
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
干预措施: BI 10773 (Drug)
Empagliflozin/Linagliptin 25/5 mg Dose.
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
干预措施: BI 10773 / BI 1356 Placebo (Drug)
Placebo add on 25 mg dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
干预措施: BI 10773 (Drug)
Placebo add on 25 mg dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
干预措施: BI 10773 / BI 1356 Placebo (Drug)
结局指标
主要结局
Change From Baseline of HbA1c After 24 Weeks of Treatment.
时间窗: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
次要结局
- Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.(Baseline and 24 weeks)
