A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 350
- 试验地点
- 83
- 主要终点
- Absolute Change in HbA1c From Baseline to Week 24
研究概览
简要总结
Primary objective:
- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.
Main secondary objective:
- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).
Other secondary objectives:
-
To assess the effect of lixisenatide compared to placebo after 24-week treatment on:
-
Fasting plasma glucose (FPG);
-
During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion;
-
7-point Self-monitored plasma glucose (SMPG) profile;
-
Body weight;
-
Change in total daily dose of basal insulin (if taken);
-
Percentage of participants requiring rescue therapy
-
Safety and tolerability;
-
To assess lixisenatide pharmacokinetic profile;
-
To assess anti-lixisenatide antibody development.
详细描述
Approximately 31 weeks including 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（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
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
干预措施: Lixisenatide (AVE0010) (Drug)
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
干预措施: Antidiabetic background therapy (Drug)
Placebo
Placebo (matched to lixisenatide) QD for 24 Weeks.
干预措施: Placebo (Drug)
Placebo
Placebo (matched to lixisenatide) QD for 24 Weeks.
干预措施: Antidiabetic background therapy (Drug)
结局指标
主要结局
Absolute 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 on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
次要结局
- Change in 2-Hour PPG From Baseline to Week 24(Baseline, Week 24)
- Change in Average 7-point SMPG Profiles 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 Gastrointestinal Disorders(Up to Day 171)
- Change in FPG From Baseline to Week 24(Baseline, Week 24)
- Change in Plasma Glucose Excursions From Baseline to Week 24(Baseline, Week 24)
- Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)(Baseline, Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia(First dose of study drug up to 3 days after the last dose administration (maximum of 171 days))
- Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia(Week 24)