A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 447
- 试验地点
- 51
- 主要终点
- Change in HbA1c
研究概览
简要总结
Primary Objective:
- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.
Secondary Objectives:
-
To assess the effects of lixisenatide over 24 weeks on :
-
percentage of patients reaching HbA1c<7% or ≤6.5%,
-
2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
-
fasting plasma glucose (FPG),
-
change in 7-point self-monitored plasma glucose (SMPG) profile),
-
body weight,
-
change in daily basal insulin dose.
-
To assess lixisenatide safety and tolerability.
-
To assess anti-lixisenatide antibody development.
详细描述
Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
干预措施: Lixisenatide (AVE0010) (Drug)
Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to week 24
次要结局
- Percentage of patients with HbA1c <7%, =<6.5%(at week 24)
- Change in 2-hour postprandial plasma glucose and plasma glucose excursion(from baseline to week 24)
- Change in fasting plasma glucose(from baseline to week 24)
- Change in 7-point self monitoring plasma glucose profile (average and each point)(from baseline to week 24)
- Change in body weight(from baseline to week 24)
- Change in daily basal insulin dose(from baseline to week 24)
- Number of patients with adverse events(24 weeks)
- Anti-lixisenatide antibody assessment(from baseline to week 24)