A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 241
- 试验地点
- 85
- 主要终点
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
研究概览
简要总结
Primary Objective:
- To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population.
- To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians).
Secondary Objective:
- To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated.
- To assess the change in daily insulin glargine dose within each ethnic/racial subgroup.
- To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.
详细描述
The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days 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
- 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
Soliqua 100/33
Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
干预措施: Insulin glargine/Lixisenatide (Drug)
Soliqua 100/33
Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
干预措施: Background therapy (Drug)
Lantus
Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
干预措施: Insulin glargine (HOE901) (Drug)
Lantus
Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
干预措施: Background therapy (Drug)
结局指标
主要结局
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
时间窗: Baseline, Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
次要结局
- Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26(Baseline, Week 26)
- Change From Baseline in Daily Insulin Glargine Dose at Week 26(Baseline, Week 26)
- Change From Baseline in Body Weight at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving HbA1c Target of <7% at Week 26(Week 26)
- Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26(Baseline, Week 26)
- Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period(Baseline to Week 26)