A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin 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
- 1,170
- 试验地点
- 273
- 主要终点
- Change in HbA1c From Baseline to Week 30
研究概览
简要总结
Primary Objective:
To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.
Secondary Objective:
To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.
详细描述
Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days 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
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
干预措施: Insulin glargine/lixisenatide Fixed Ratio Combination (Drug)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
干预措施: Metformin (Drug)
Insulin Glargine
Insulin glargine QD for 30 weeks. Dose individually adjusted.
干预措施: Insulin glargine (HOE901) (Drug)
Insulin Glargine
Insulin glargine QD for 30 weeks. Dose individually adjusted.
干预措施: Metformin (Drug)
Lixisenatide
Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).
干预措施: Lixisenatide (AVE0010) (Drug)
Lixisenatide
Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).
干预措施: Metformin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 30
时间窗: Baseline, Week 30
Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine. Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
次要结局
- Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30(Week 30)
- Change in Plasma Glucose Excursion From Baseline to Week 30(Baseline, Week 30)
- Change in Body Weight From Baseline to Week 30(Baseline, Week 30)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30(Baseline, Week 30)
- Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30(Baseline, Week 30)
- Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30(Week 30)
- Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period(Baseline up to Week 30)
- Average Daily Insulin Glargine Dose at Week 30(Week 30)
- Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30(Baseline, Week 30)
- Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period(Baseline up to Week 30)
- Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period(Baseline up to Week 30)
- Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year(First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days))
- Percentage of Participants With Documented Symptomatic Hypoglycemia(First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days))
- Percentage of Participants With Severe Symptomatic Hypoglycemia(First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days))