A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 514
- 试验地点
- 124
- 主要终点
- Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.
Secondary Objectives:
To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes.
To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
详细描述
The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.
Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.
All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension 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)
Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.
Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.
干预措施: Insulin glargine/lixisenatide fixed ratio combination (Drug)
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
干预措施: liraglutide (Drug)
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
干预措施: exenatide (Drug)
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
干预措施: exenatide extended-release (Drug)
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
干预措施: albiglutide (Drug)
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
干预措施: dulaglutide (Drug)
结局指标
主要结局
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
时间窗: Baseline, Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period
时间窗: Baseline, Week 52
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
次要结局
- Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period(Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period(Baseline, Week 26)
- Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period(Baseline, Week 52)
- Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period(From Baseline to Week 26)
- Change From Baseline in Body Weight at Week 26: Core Period(Baseline, Week 26)
- Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period(Week 26)
- Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period(Baseline, Week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period(Baseline, Week 52)
- Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period(Baseline, Week 26)
- Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period(Baseline, Week 52)
- Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period(Baseline, Week 52)
- Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period(From Week 26 to Week 52)
- Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period(Baseline, Week 26)
- Change From Baseline in Body Weight to Week 52: Single Arm Extension Period(Baseline, Week 52)
- Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period(From Baseline to Week 26)
- Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period(From Baseline to Week 52)