A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without 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
- 736
- 试验地点
- 236
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.
Secondary Objective:
To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.
详细描述
Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days 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
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
干预措施: Insulin glargine/lixisenatide (HOE901/AVE0010) (Drug)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
干预措施: Metformin (Background Drug) (Drug)
Insulin glargine
Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.
干预措施: Insulin glargine (HOE901) (Drug)
Insulin glargine
Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.
干预措施: Metformin (Background Drug) (Drug)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30
时间窗: Baseline, Week 30
Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
次要结局
- 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 [FRC], 210 days [Insulin glargine]))
- Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30(Week 30)
- Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30(Baseline, Week 30)
- Change in Body Weight 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)
- Change in Daily Insulin Glargine Dose From Baseline to Week 30(Baseline, 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)
- Change in FPG From Baseline to Week 30(Baseline, Week 30)
- Change in 2-hour PPG From Baseline to Week 30(Baseline, Week 30)
- Percentage of Participants Reaching HbA1c <7.0% 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 [FRC], 210 days [Insulin glargine]))
- 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 [FRC], 210 days [Insulin glargine]))