A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 265
- 试验地点
- 32
- 主要终点
- Change in glycated hemoglobin (HbA1c)%
研究概览
简要总结
Primary Objective:
To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling.
Secondary Objective:
To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).
详细描述
The maximum duration of study per patient is approximately 29 weeks including a 2-week screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment safety 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
- None
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
iGlarlixi DAILY
Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
干预措施: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 (Drug)
iGlarlixi WEEKLY
Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
干预措施: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 (Drug)
结局指标
主要结局
Change in glycated hemoglobin (HbA1c)%
时间窗: Baseline to Week 26
Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)
次要结局
- Change in FPG from baseline to Week 26(Baseline to Week 26)
- Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26(Baseline to Week 26)
- Insulin glargine dose(At Week 26)
- Percentage of patients requiring rescue therapy(Baseline to Week 26)
- Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks(Baseline to Week 26)
- Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks(Baseline to Week 26)
- Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12(Baseline to Week 12)
- Change in fasting plasma glucose (FPG) from baseline to Week 12(Baseline to Week 12)
- Change in 7-point SMPG profile from baseline to Week 26(Baseline to Week 26)
- Change in body weight from baseline to Week 26(Baseline to Week 26)
- Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks(Baseline to Week 26)
- Change in fasting SMPG from baseline to Week 26(Baseline to Week 26)
- Change in 7-point SMPG profile from baseline to Week 12(Baseline to Week 12)
- Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks(Baseline to Week 26)
- Percentage of patients achieving HbA1c ≤7% at Week 26(At Week 26)