A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of plasma glucose concentrations
研究概览
简要总结
Primary Objective:
To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).
Secondary Objectives:
- To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
- To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
- To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
详细描述
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（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
Insulin glargine/ lixisenatide dose 1 Test 1
Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
干预措施: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 (Drug)
Insulin glargine/ lixisenatide dose 2 Test 2
Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
干预措施: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 (Drug)
Placebo - Reference 1
Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
干预措施: Placebo (Drug)
Insulin glargine (Lantus) - Reference 2
Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition
干预措施: Insulin glargine HOE901 (Drug)
结局指标
主要结局
Measurement of plasma glucose concentrations
时间窗: 1 day (D1) in each treatment period
次要结局
- Measurement of serum insulin concentrations(1 day (D1) in each treatment period)
- Measurement of serum C-peptide concentrations(1 day (D1) in each treatment period)
- Measurement of plasma glucagon concentrations(1 day (D1) in each treatment period)
- Measurement of plasma lixisenatide concentrations(1 day (D1) in each treatment period)
- Number of patients with hypoglycemic events(Up to 2 weeks after each treatment)
- Number of patients with adverse events(Up to 2 weeks after each treatment)
- Measurement of anti-lixisenatide antibodies(2 days (prior to first dosing and end of study visit))
- Measurement of anti-insulin antibodies(2 days (prior to first dosing and end of study visit))