A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 513
- 试验地点
- 122
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
详细描述
The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized 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.
Metformin will be continued.
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.
Metformin will be continued.
干预措施: Metformin (Drug)
insulin glargine
Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted.
Metformin will be continued.
干预措施: Insulin glargine U100 (HOE901) (Drug)
insulin glargine
Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted.
Metformin will be continued.
干预措施: Metformin (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 from baseline in blood glucose excursion during standardized meal test(Baseline, 26 weeks)
- Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value)(Baseline, 26 weeks)
- Change from baseline in body weight(Baseline, 26 weeks)
- Change from baseline in FPG(Baseline, 26 weeks)
- Change from baseline in daily dose of insulin glargine(Baseline, 26 weeks)
- Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia(26 weeks)
- Percentage of patients requiring a rescue therapy(26 weeks)
- Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test(Baseline, 26 weeks)
- Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia(26 weeks)
- Percentage of patients reaching HbA1c <7% with no body weight gain(26 weeks)
- Number of hypoglycemic events(26 weeks)
- Number of adverse events(26 weeks)
- Measurement of anti-lixisenatide antibodies from baseline(Baseline, 26 weeks)
- Measurement of anti-insulin antibodies from baseline(Baseline, 26 weeks)