A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 451
- 试验地点
- 82
- 主要终点
- Change in HbA1c From Baseline to Week 24
研究概览
简要总结
Primary Objective:
- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
-
To assess the effect of the 2 lixisenatide regimens on:
-
The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
-
Fasting Plasma Glucose (FPG)
-
7-point Self-Monitored Plasma Glucose (SMPG) profiles
-
Body weight
-
To assess the safety and tolerability of the 2 lixisenatide regimens
详细描述
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment 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
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Lixisenatide (AVE0010) (Drug)
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Self-injector pen device (OptiClik®) (Device)
Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Metformin (Drug)
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Lixisenatide (AVE0010) (Drug)
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Self-injector pen device (OptiClik®) (Device)
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: Baseline, Week 24
Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
次要结局
- Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24(Week 24)
- Change in Average 7-point SMPG Profiles From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period(Week 24)
- Change in FPG From Baseline to Week 24(Baseline, Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24(Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period(Week 24)
- Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24(Week 24)
- Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24(Baseline, Week 24)