A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on 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
- 247
- 试验地点
- 13
- 主要终点
- Change in HbA1c
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 by demonstrating change in glycosylated hemoglobin (HbA1c).
Secondary Objectives:
- To assess the effects of the FRC in comparison with insulin glargine on:
- Percentage of patients reaching HbA1c targets (<7% );
- Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
- Body weight
- Fasting Plasma Glucose (FPG);
- Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
- 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
- Insulin glargine dose.
- To assess the safety and tolerability in each treatment group.
详细描述
The maximum study duration per patient is 33 weeks.
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 64 Years（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
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
干预措施: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010) (Drug)
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
干预措施: Metformin (Drug)
Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
干预措施: Insulin Glulisine (HMR1964) (Drug)
Control Drug
Insulin glargine (Lantus®)
干预措施: INSULIN GLARGINE (HOE901) (Drug)
Control Drug
Insulin glargine (Lantus®)
干预措施: Metformin (Drug)
Control Drug
Insulin glargine (Lantus®)
干预措施: Insulin Glulisine (HMR1964) (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From baseline to Week 24
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24
次要结局
- Change in 2-hour Post prandial glucose (PPG)(From baseline to Week 24)
- Patients with HbA1c <7%(At Week 24)
- Change in body weight(From baseline to Week 24)
- Patients with HbA1c <7% with no body weight gain and no hypoglycemia(At Week 24)
- Change in Fasting Plasma Glucose(From baseline to Week 24)
- Adverse events (AE)(Up to 33 weeks)
- Patients with HbA1c <7% with no body weight gain(At Week 24)
- Change in SMPG profiles(From baseline to Week 24)