NCT01499095已完成3 期
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 811
- 试验地点
- 213
- 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 insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus
Secondary Objective:
- To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
详细描述
The maximum study duration was up to approximately 58 weeks per participants, consisting of:
- up to 2 week screening period
- 6-month comparative efficacy and safety treatment period
- 6-month comparative safety extension period
- 4-week safety follow-up period in a subset of participants
- a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
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
Experimental
干预措施: HOE901-U300 (new formulation of insulin glargine) (Drug)
Lantus
Active Comparator
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 measurements performed before initiation of rescue therapy were considered in the analysis.
次要结局
- Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint(Week 9 Up to Month 6)
- Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With HbA1c <7% 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 Endpoint(Month 6)
- Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12(Up to Month 12)
研究者
研究点 (213)
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