International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 184
- 试验地点
- 16
- 主要终点
- Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
研究概览
简要总结
Primary Objective:
To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).
Secondary Objectives:
- To assess effect of lixisenatide versus SU on:
- Changes in glycemic control;
- Changes in body weight.
- To assess overall safety of lixisenatide and SU.
详细描述
The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).
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
Lyxumia
Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: Lixisenatide (AVE0010) (Drug)
Lyxumia
Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: metformin (Drug)
Lyxumia
Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: basal insulin (Drug)
Sulfonylurea
Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: Sulfonylurea (Drug)
Sulfonylurea
Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: metformin (Drug)
Sulfonylurea
Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
干预措施: basal insulin (Drug)
结局指标
主要结局
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
时间窗: Approximately 30 days (from start to end of Ramadan holy month)
次要结局
- Mean change in HbA1c(Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan)
- Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)(At 0-4 weeks pre- and 0-4 weeks post-Ramadan)
- Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)(Last 14 days of Ramadan month)
- Mean change in body weight(Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan)
- Percentage of patients with HbA1C <7%(At 0-4 weeks pre- and 0-4 weeks post-Ramadan)
- Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)(At pre-Ramadan visit)