A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 321
- 试验地点
- 61
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.
详细描述
Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 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
- 20 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
LixiLan
LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.
Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
干预措施: Insulin glargine/Lixisenatide (HOE901/AVE0010) (Drug)
LixiLan
LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.
Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
干预措施: Oral anti-diabetic drugs (Drug)
lixisenatide
Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period.
Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
干预措施: Lixisenatide (AVE0010) (Drug)
lixisenatide
Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period.
Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
干预措施: Oral anti-diabetic drugs (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, 26 weeks
次要结局
- Percentage of patients reaching HbA1c <7% or ≤6.5%(26 weeks)
- Change in from baseline in 7 point self-monitored plasma profiles(Baseline, 26 weeks)
- Change from baseline in body weight(Baseline, 26 weeks)
- Change in daily dose of insulin glargine for the combination group(Day 1, 26 weeks)
- Number of adverse events(26 weeks, 52 weeks)
- Change from baseline in fasting plasma glucose(Baseline, 26 weeks)
- Percentage of patients reaching HbA1c <7% with no body weight gain(26 weeks)
- Measurement of anti-insulin antibodies from baseline(Baseline, 26 weeks, 52 weeks)
- Percentage of patients requiring a rescue therapy(26 weeks)
- Number of hypoglycemic events(26 weeks, 52 weeks)
- Measurement of anti-lixisenatide antibodies from baseline(Baseline, 26 weeks, 52 weeks)