A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 426
- 试验地点
- 45
- 主要终点
- Change in HbA1c
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.
Secondary Objectives:
- To assess the effects of iGlarLixi in comparison with insulin glargine
- To assess the safety in each treatment group
详细描述
The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), 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
- 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
Soliqua (insulin glargine/lixisenatide)
iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
干预措施: Insulin glargine/Lixisenatide (HOE901/AVE0010) (Drug)
Soliqua (insulin glargine/lixisenatide)
iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
干预措施: Metformin (Drug)
Lantus (insulin glargine)
Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
干预措施: Insulin glargine (HOE901) (Drug)
Lantus (insulin glargine)
Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
干预措施: Metformin (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From Baseline to Week 30
Change in glycated hemoglobin (HbA1c) from baseline to Week 30
次要结局
- Patients with HbA1c <7.0%(At Week 30)
- Patients with HbA1c ≤ 6.5%(At Week 30)
- Change in postprandial plasma glucose (PPG)(From Baseline to Week 30)
- Change in self-monitored plasma glucose (SMPG) profile(From Baseline to Week 30)
- Patients with HbA1c <7.0% with no body weight gain(At Week 30)
- Change in body weight(From Baseline to Week 30)
- Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia(At Week 30)
- Patients requiring rescue therapy(From Baseline to Week 30)
- Adverse events (AEs)(From Baseline to Week 30)
- Immunogenicity (antibody variables)(From Baseline to Week 30)
- Change in fasting plasma glucose (FPG)(From Baseline to Week 30)
- Confirmed hypoglycemia(From Baseline to Week 30)