A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 323
- 试验地点
- 70
- 主要终点
- Change in HbA1c From Baseline to Week 24
研究概览
简要总结
Primary Objective:
- The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.
Secondary Objectives:
-
To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:
-
Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
-
Percentage of participants reaching HbA1c <7% or ≤6.5%;
-
7-point Self-Monitored Plasma Glucose (SMPG) profile;
-
Body weight;
-
Insulin glargine dose
-
Fasting Plasma Glucose (FPG);
-
Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
-
To assess safety and tolerability of insulin glargine/lixisenatide FRC.
详细描述
Approximately 27 weeks including a 24-week treatment 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
Insulin glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC injected once daily (QD) for 24 weeks. Dose individually adjusted.
干预措施: Insulin glargine /lixisenatide Fixed Ratio Combination (Drug)
Insulin glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC injected once daily (QD) for 24 weeks. Dose individually adjusted.
干预措施: Metformin (Background drug) (Drug)
Insulin glargine
Insulin glargine QD for 24 weeks. Dose individually adjusted.
干预措施: Insulin glargine (Drug)
Insulin glargine
Insulin glargine QD for 24 weeks. Dose individually adjusted.
干预措施: Metformin (Background drug) (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: Baseline, Week 24
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).
次要结局
- Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24(Baseline, Week 24)
- Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24(Baseline, Week 24)
- Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24(Baseline, Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Average Daily Insulin Glargine Dose at Week 24(Week 24)
- Change in FPG From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period(Baseline up to Week 24)
- Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24(Week 24)
- Change in 30-minute and 1-hour PPG From Baseline to Week 24(Baseline, Week 24)
- Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period(Baseline up to Week 24)
- Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24(Week 24)
- Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia(First dose of study drug up to 3 days after the last dose administration (maximum of 219 days))