Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With 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
- 597
- 试验地点
- 82
- 主要终点
- Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26
研究概览
简要总结
Primary Objective:
To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.
Secondary Objectives:
- To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study.
- To assess the relationship of AIAs with efficacy and safety.
- To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c).
- To assess safety of SAR341402 and NovoLog/NovoRapid.
详细描述
The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration was 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
SAR341402
SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
干预措施: Insulin aspart (Drug)
SAR341402
SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
干预措施: Insulin glargine (HOE901) (Drug)
NovoLog/NovoRapid
NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52.
干预措施: NovoLog/NovoRapid (Drug)
NovoLog/NovoRapid
NovoLog/NovoRapid SC, 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 Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26
时间窗: Baseline, Week 26
All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae).
次要结局
- Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions(From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52)
- Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample(From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52)
- Change in HbA1c From Baseline to Week 52(Baseline, Week 52)
- Percentage of Participants With HbA1c <7% at Week 26 and Week 52(Week 26 and Week 52)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52(Baseline, Week 26, and Week 52)
- Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52(Baseline, Week 26, and Week 52)
- Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52(Baseline, Week 26, and Week 52)
- Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point(Baseline, Week 26, and Week 52)
- Number of Participants With at Least One Hypoglycemic Event(From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52)
- Number of Hypoglycemia Events Per Participant-Year(From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52)
- Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)(From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52)