Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 507
- 试验地点
- 89
- 主要终点
- Change in HbA1c From Baseline to Week 26
研究概览
简要总结
Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.
To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.
To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.
To assess safety of SAR342434 and Humalog.
详细描述
The study consisted of a:
- Up to 2 weeks screening period
- 26-week treatment period
- 26-week comparative safety extension period
- 1-day follow-up period
- The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up
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
SAR342434
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
干预措施: SAR342434 (Drug)
SAR342434
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
干预措施: Insulin glargine HOE901 (Drug)
Humalog
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
干预措施: Humalog (Drug)
Humalog
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
干预措施: Insulin glargine HOE901 (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 26
时间窗: Baseline, Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.
次要结局
- Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26(Baseline, Week 26)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26(Baseline, Week 26)
- Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26(Baseline, Week 26)
- Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions(First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days))
- Percentage of Participants With HbA1c <7.0% at Week 26(Week 26)
- Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year(First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days))
- Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)(First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days))