6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs 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
- 878
- 试验地点
- 217
- 主要终点
- Change in HbA1c From Baseline to Month 6 Endpoint
研究概览
简要总结
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of:
- occurrence of nocturnal hypoglycemia
详细描述
The maximum study duration was up to approximately 54 weeks per participant, consisting of:
- Up to 2 week screening period; it can be exceptionally extended of up to one additional week
- 6-month comparative efficacy and safety treatment period
- 6-month comparative safety extension period
- 2-day post-treatment safety 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
HOE901-U300
干预措施: HOE901-U300 (new formulation of insulin glargine) (Drug)
Lantus
干预措施: Lantus (insulin glargine) (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Month 6 Endpoint
时间窗: Baseline, Month 6
Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
次要结局
- Percentage of Participants With HbA1c <7% at Month 6(Month 6)
- Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Variability of Preinjection SMPG at Month 6 Endpoint(Month 6)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6(Month 6)
- Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12(Up to 12 months)
- Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6(Week 9 Up to Month 6)
- Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6(Baseline, Month 6)
- Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Daily Basal Insulin Dose From Baseline to Month 6(Baseline, Month 6)
- Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint(Baseline, Month 6)