6-Month, Multicenter, Randomized, 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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 604
- 试验地点
- 54
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
Primary Objective:
To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia.
- To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia).
- To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia).
- To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative).
- To assess the safety and tolerability of insulin glargine (U300).
- To assess the development of anti-insulin glargine antibodies (AIA).
详细描述
The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 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
Toujeo - insulin glargine (U300)
Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
干预措施: Insulin glargine (U300) (Drug)
Toujeo - insulin glargine (U300)
Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
干预措施: Non-insulin antihyperglycemic drugs (Drug)
Lantus - insulin glargine
Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
干预措施: Insulin glargine (Drug)
Lantus - insulin glargine
Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
干预措施: Non-insulin antihyperglycemic drugs (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: Baseline, 6 months
次要结局
- Percentage (%) of patients with HbA1c <7.0%(6 months)
- Percentage (%) of patients with at least one hypoglycemia(Baseline, up to 6 months)
- Percentage (%) of patients with at least one nocturnal hypoglycemia(Baseline, up to 6 months)
- Percentage (%) of patients with HbA1c ≤6.5%(6 months)
- Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)(6 months)
- Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)(6 months)
- Percentage (%) of patients requiring rescue therapy(6 months)
- Change in fasting plasma glucose(Baseline, 6 months)
- Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles(Baseline, 6 months)
- Change of mean 24-hour plasma glucose(Baseline, 6 months)
- Change in variability of plasma glucose profile(Baseline, 6 months)
- Change in daily basal insulin dose(Baseline, 6 months)