A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 131
- 主要终点
- Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
研究概览
简要总结
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
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 low dose
Empagliflozin tablets once daily
干预措施: Empagliflozin (Drug)
Empagliflozin high dose
Empagliflozin tablets once daily
干预措施: Empagliflozin (Drug)
Placebo
Placebo tablets matching empagliflozin once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
时间窗: Baseline to week 26
Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )
时间窗: Baseline to week 26
Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \[OC-AD\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
次要结局
- Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26(Week 23 to 26)
- Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26(Baseline to week 26)
- Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26(Week 23 to 26)
- Change From Baseline in Body Weight at Week 26(Baseline to week 26)
- Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)(Week 5 to Week 26, Week 1 to Week 26)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26(Baseline to week 26)